Suppliers

Edan Instruments, Inc.

Manufacturer and brand owner in Shenzhen, Guangdong, China. 56 device types, 106 products catalogued, 94 clearances.

Registry build 21.09.26

Edan Instruments, Inc. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Vectorcardiograph and 53 other device types. 104 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2009.

56device types registered with the FDA
106products catalogued under its own name
94510(k) clearances
1recall

Registration

FDA registration record for Edan Instruments, Inc.
Registered name EDAN INSTRUMENTS, INC.
Status Registered
Registration expires 2026
Registration number 3003971136
FEI number 3003971136
DUNS 529173163
Establishment type Contract manufacturer, Manufacturer

Chinese Registration

Chinese company register details for Edan Instruments, Inc.
Chinese legal name 深圳市理邦精密仪器股份有限公司
Unified social credit code 914403001923672010
Source export sales certificate, Guangdong medical products administration

Location

Address of Edan Instruments, Inc.
City Shenzhen
Province Guangdong
Address #15 Jinhui Road, Jinsha Community
Postal code 518122
Country China

What It Makes

Device types Edan Instruments, Inc. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Alarm, Blood-Pressure Class 2 Fetal & maternal monitor, model: F15A, F15A Air 2025 7
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Class 2 Patient monitor:Waveline EZ MAX, Patient monitor iM60A, PM-2000XL Plus, iM60, iM70 Patient monitor, Patient monitor LM-10, LM-12, DRE Waveline SV10; DRE Waveline SV12; DRE Waveline SV15 and 23 more 2010 29
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 DRE Waveline SV10; DRE Waveline SV12; DRE Waveline SV15, Patient Monitor, models:iX10, iX12, iX15, Tecme Patient Monitor iX10; Tecme Patient Monitor iX12; Tecme Patient Monitor iX15;, Patient Monitor LMPLUS-12, LMPLUS-15, LMPLUS-17, MM17, Patient Monitor elite V5, elite V6, elite V8 and 7 more 2016 5
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 Patient monitor:Waveline EZ MAX, Patient monitor iM60A, PM-2000XL Plus, iM60, iM70 Patient monitor, Patient monitor LM-10, LM-12, DRE Waveline SV10; DRE Waveline SV12; DRE Waveline SV15 and 16 more 2011 6
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Class 2 Patient monitor:Waveline EZ MAX, Patient monitor iM60A, PM-2000XL Plus, iM60, iM70 Patient monitor, Patient monitor LM-10, LM-12, DRE Waveline SV10; DRE Waveline SV12; DRE Waveline SV15 and 16 more 2011 6
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 DRE Waveline SV10; DRE Waveline SV12; DRE Waveline SV15, Patient Monitor, models:iX10, iX12, iX15, Tecme Patient Monitor iX10; Tecme Patient Monitor iX12; Tecme Patient Monitor iX15;, Patient Monitor LMPLUS-12, LMPLUS-15, LMPLUS-17, MM17, Patient Monitor elite V5, elite V6, elite V8 and 7 more 2016 5
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Class 2 Patient monitor:Waveline EZ MAX, Patient monitor iM60A, PM-2000XL Plus, iM60, iM70 Patient monitor, Patient monitor LM-10, LM-12, DRE Waveline SV10; DRE Waveline SV12; DRE Waveline SV15 and 16 more 2011 6
Analyzer, Gas, Oxygen, Gaseous-Phase Class 2 Patient monitor:Waveline EZ MAX, Patient monitor iM60A, PM-2000XL Plus, iM60, iM70 Patient monitor, Patient monitor LM-10, LM-12, DRE Waveline SV10; DRE Waveline SV12; DRE Waveline SV15 and 18 more 2011 8
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 DRE Waveline SV10; DRE Waveline SV12; DRE Waveline SV15, Patient Monitor, models:iX10, iX12, iX15, Tecme Patient Monitor iX10; Tecme Patient Monitor iX12; Tecme Patient Monitor iX15;, Patient Monitor LMPLUS-12, LMPLUS-15, LMPLUS-17, MM17, Patient Monitor elite V5, elite V6, elite V8 and 7 more 2016 5
Cable, Transducer And Electrode, Patient, (Including Connector) Class 2 Patient Monitor models PM-2000A,PM-2000A+,PM-2000A Pro, Patient Monitor model Waveline EZx, Patient Monitor models iM8,iM8A,iM8B, Patient monitor:Waveline EZ MAX, Patient monitor iM60A, PM-2000XL Plus and 6 more 2011 22
Calibrator, Multi-Analyte Mixture Class 2 i15A Hematocrit Control,i15A Blood Gas and Electrolyte Control,i15A Calibrant Fluid Pack, i15 Blood Gas and Chemistry Analysis System, i15 Calibrant Fluid Pack,i15 Blood Gas and Electrolyte Control, i15 Hematocrit Control, i15A Blood Gas and Chemistry Analysis System 2016 3
Colposcope (And Colpomicroscope), Exempt Class 2 Video Colposcope, Models C6A HD, C3A, C6A, Video Colposcope, models: C9 UHD, C12 UHD, Video Colposcope, models: C9A UHD, C12A UHD 2017 4
Computer, Blood-Pressure Class 2 Patient Monitor models PM-2000A,PM-2000A+,PM-2000A Pro, Patient Monitor model Waveline EZx, Patient Monitor models iM8,iM8A,iM8B, Patient monitor:Waveline EZ MAX, Patient monitor iM60A, PM-2000XL Plus and 25 more 2011 12
Computer, Diagnostic, Programmable Class 2 Holter System, models SE-2003 and SE-2012, Holter System, model LH-12, Holter ECG and ABP system (Model: HolterABP) 2016 10
Continuous Measurement Thermometer Class 2 Patient Monitor models PM-2000A,PM-2000A+,PM-2000A Pro, Patient Monitor model Waveline EZx, Patient Monitor models iM8,iM8A,iM8B, Vital Signs Monitor, models: iM3s, iM3As, iM3Bs, iHM3s, Fetal Monitor, model LC-TWIN, Fetal & maternal monitor models FM-9000, FM-9000Plus and 37 more 2011 115
Control, Hematocrit Class 2 i15A Hematocrit Control,i15A Blood Gas and Electrolyte Control,i15A Calibrant Fluid Pack, i15 Blood Gas and Chemistry Analysis System, i15 Calibrant Fluid Pack,i15 Blood Gas and Electrolyte Control, i15 Hematocrit Control, i15A Blood Gas and Chemistry Analysis System 2016 1
Controls For Blood-Gases, (Assayed And Unassayed) Class 1 i15A Hematocrit Control,i15A Blood Gas and Electrolyte Control,i15A Calibrant Fluid Pack, i15 Blood Gas and Chemistry Analysis System, i15 Calibrant Fluid Pack,i15 Blood Gas and Electrolyte Control, i15 Hematocrit Control, i15A Blood Gas and Chemistry Analysis System 2016 1
Detector And Alarm, Arrhythmia Class 2 Patient Monitor models PM-2000A,PM-2000A+,PM-2000A Pro, Patient Monitor model Waveline EZx, Patient Monitor models iM8,iM8A,iM8B, Fetal Monitor, model LC-TWIN, Fetal & maternal monitor models FM-9000, FM-9000Plus, Fetal Monitor, Models FM-3000 and 29 more 2012 10
Electrocardiograph Class 2 PC ECG, model PADECG, Electrocardiograph models SE-12,SE-1200,SE-12 Express,SE-1200 Express, Electrocardiograph models: ECG-12 Plus; ECG-12 Plus/ST; ECG-12; ECG-12 B; ECG-12 C; ECG-1200; ECG-1200 Plus, Electrocardiograph models: CardioExpress SL12, SL12A,RECORDING PAPER Z-FOLD, Electrocardiograph models: LE-12CH, Fetal Monitor, model LC-TWIN and 40 more 2012 18
Electrocardiograph, Ambulatory (Without Analysis) Class 2 Holter ECG and ABP system Model:SA-20;SA-19;SA-18;SA-16;SA-15, Holter System, models SE-2003 and SE-2012, Holter System, model LH-12 2016 4
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Class 2 i15A Hematocrit Control,i15A Blood Gas and Electrolyte Control,i15A Calibrant Fluid Pack, i15 Blood Gas and Chemistry Analysis System, i15 Calibrant Fluid Pack,i15 Blood Gas and Electrolyte Control, i15 Hematocrit Control, i15A Blood Gas and Chemistry Analysis System 2016 1
Electrode, Cutaneous Class 2 Telemetry Transmitter iT20 2017 47
Electrode, Ion Specific, Calcium Class 2 i15A Hematocrit Control,i15A Blood Gas and Electrolyte Control,i15A Calibrant Fluid Pack, i15 Blood Gas and Chemistry Analysis System, i15 Calibrant Fluid Pack,i15 Blood Gas and Electrolyte Control, i15 Hematocrit Control, i15A Blood Gas and Chemistry Analysis System 2016 1
Electrode, Ion Specific, Potassium Class 2 i15A Hematocrit Control,i15A Blood Gas and Electrolyte Control,i15A Calibrant Fluid Pack, i15 Blood Gas and Chemistry Analysis System, i15 Calibrant Fluid Pack,i15 Blood Gas and Electrolyte Control, i15 Hematocrit Control, i15A Blood Gas and Chemistry Analysis System 2016 2
Electrode, Ion Specific, Sodium Class 2 i15A Hematocrit Control,i15A Blood Gas and Electrolyte Control,i15A Calibrant Fluid Pack, i15 Blood Gas and Chemistry Analysis System, i15 Calibrant Fluid Pack,i15 Blood Gas and Electrolyte Control, i15 Hematocrit Control, i15A Blood Gas and Chemistry Analysis System 2016 2
Electrode, Ion-Specific, Chloride Class 2 i15A Hematocrit Control,i15A Blood Gas and Electrolyte Control,i15A Calibrant Fluid Pack, i15 Blood Gas and Chemistry Analysis System, i15 Calibrant Fluid Pack,i15 Blood Gas and Electrolyte Control, i15 Hematocrit Control, i15A Blood Gas and Chemistry Analysis System 2016 2
Flowmeter, Blood, Cardiovascular Class 2 SD3 Series Ultrasonic Pocket Doppler: SD3 LITE, SD3, SD3 PLUS, SD3 PRO, SD3 VASCULAR, Ultrasonic Pocket Doppler,Model: SD1 2015 4
Instrument, Hematocrit, Automated Class 2 i15A Hematocrit Control,i15A Blood Gas and Electrolyte Control,i15A Calibrant Fluid Pack, i15 Blood Gas and Chemistry Analysis System, i15 Calibrant Fluid Pack,i15 Blood Gas and Electrolyte Control, i15 Hematocrit Control, i15A Blood Gas and Chemistry Analysis System 2016 1
Medical Device Data System Class 1 Vista Gateway 2026 11
Monitor, Blood-Flow, Ultrasonic Class 2 Ultrasonic pocket doppler models PD-100A,PD-100Plus, PD-100Pro,PD-1000,PD-1000Plus,PD-1000Pro,PD-100B, Ultrasonic pocket doppler models Sonotrax vascular, Sonotrax Lite, Sonotrax BASIC, Ultrasonic Pocket Doppler, models LFD-PRO, LFD-PLUS, Ultrasonic Pocket Doppler, models Sonotrax pro, SonoTrax BASIC A, SonoTrax II, SonoTrax II Pro 2010 1
Monitor, Breathing Frequency Class 2 DRE Waveline SV10; DRE Waveline SV12; DRE Waveline SV15, Patient Monitor, models:iX10, iX12, iX15, Tecme Patient Monitor iX10; Tecme Patient Monitor iX12; Tecme Patient Monitor iX15;, Patient Monitor LMPLUS-12, LMPLUS-15, LMPLUS-17, MM17, Patient Monitor elite V5, elite V6, elite V8 and 10 more 2016 8
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Class 2 Patient Monitor models PM-2000A,PM-2000A+,PM-2000A Pro, Patient Monitor model Waveline EZx, Patient Monitor models iM8,iM8A,iM8B, Fetal Monitor, model LC-TWIN, Fetal & maternal monitor models FM-9000, FM-9000Plus, Fetal Monitor, Models FM-3000 and 32 more 2011 9
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Class 2 Vital Signs Monitor, models: iM3s, iM3As, iM3Bs, iHM3s 2021 17
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Class 2 Patient Monitor models PM-2000A,PM-2000A+,PM-2000A Pro, Patient Monitor model Waveline EZx, Patient Monitor models iM8,iM8A,iM8B, Patient Monitor, model iM20, PM-2000TM, Vista 300; Vista 300 S and 32 more 2011 9
Monitor, St Segment With Alarm Class 2 Patient monitor:Waveline EZ MAX, Patient monitor iM60A, PM-2000XL Plus, iM60, iM70 Patient monitor, Patient monitor LM-10, LM-12, DRE Waveline SV10; DRE Waveline SV12; DRE Waveline SV15 and 23 more 2011 7
Monitor, Ultrasonic, Fetal Class 2 SD3 Series Ultrasonic Pocket Doppler: SD3 LITE, SD3, SD3 PLUS, SD3 PRO, SD3 VASCULAR, Ultrasonic pocket doppler models PD-100A,PD-100Plus, PD-100Pro,PD-1000,PD-1000Plus,PD-1000Pro,PD-100B, Ultrasonic pocket doppler models Sonotrax vascular, Sonotrax Lite, Sonotrax BASIC, Ultrasonic Pocket Doppler, models LFD-PRO, LFD-PLUS, Ultrasonic Pocket Doppler, models Sonotrax pro, SonoTrax BASIC A, SonoTrax II, SonoTrax II Pro, Ultrasonic Pocket Doppler,Model: SD1 and 2 more 2010 13
Monitor, Uterine Contraction, External (For Use In Clinic) Class 2 Fetal & maternal monitor, model: F15A, F15A Air 2025 2
Oximeter Class 2 Patient Monitor models PM-2000A,PM-2000A+,PM-2000A Pro, Patient Monitor model Waveline EZx, Patient Monitor models iM8,iM8A,iM8B, Vital Signs Monitor, models: iM3s, iM3As, iM3Bs, iHM3s, Fetal Monitor, model LC-TWIN, Fetal & maternal monitor models FM-9000, FM-9000Plus and 46 more 2009 70
Plethysmograph, Impedance Class 2 Patient Monitor LMPLUS-12, LMPLUS-15, LMPLUS-17, MM17, Patient Monitor elite V5, elite V6, elite V8, PM-2000M 15, Patient Monitor Model PM-2000M, RespArray and 1 more 2016 5
Recorder, Magnetic Tape, Medical Class 2 Holter ECG and ABP system Model:SA-20;SA-19;SA-18;SA-16;SA-15 2023 4
Recorder, Paper Chart Class 1 Patient Monitor models M50 and M80 2011 9
Spirometer, Monitoring (W/Wo Alarm) Class 2 Patient Monitor LMPLUS-12, LMPLUS-15, LMPLUS-17, MM17, Patient Monitor elite V5, elite V6, elite V8, PM-2000M 15, Patient Monitor Model PM-2000M 2016 5
Stimulator, Muscle, Powered Class 2 Stimulation System: PA4 Pro; PA4; PA36; PA38; PR4 Pro; PR4; PR36; PR38; Q3; Q9; Q10; Q12; S6; S9; S10; S12; 2024 33
Stimulator, Nerve, Transcutaneous, For Pain Relief Class 2 Stimulation System: PA4 Pro; PA4; PA36; PA38; PR4 Pro; PR4; PR36; PR38; Q3; Q9; Q10; Q12; S6; S9; S10; S12; 2024 32
System, Imaging, Pulsed Doppler, Ultrasonic Class 2 Diagnostic Ultrasound System, Models: Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25, Acclarix LX28, Diagnostic Ultrasound System, Models: Acclarix AX18,, Diagnostic Ultrasound System, Models: Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15,, Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28,, Diagnostic Ultrasound System, model: Acclarix LX8, Diagnostic Ultrasound System, models: Acclarix AX8 , Acclarix AX7 and 15 more 2017 22
System, Imaging, Pulsed Echo, Ultrasonic Class 2 Digital Ultrasonic Diagnostic Imaging System models DUS-3000,DUS-3000Plus, Digital Ultrasonic Diagnostic Imaging System models DUS3, DUS 6, UMS 600, P3, Digital Ultrasonic Diagnostic Imaging System DUS60, L-USG-P and 22 more 2009 37
System, Measurement, Blood-Pressure, Non-Invasive Class 2 Patient Monitor models PM-2000A,PM-2000A+,PM-2000A Pro, Patient Monitor model Waveline EZx, Patient Monitor models iM8,iM8A,iM8B, Holter ECG and ABP system Model:SA-20;SA-19;SA-18;SA-16;SA-15, Vital Signs Monitor, models: iM3s, iM3As, iM3Bs, iHM3s, Fetal Monitor, model LC-TWIN and 39 more 2011 98
System, Monitoring, Perinatal Class 2 Fetal Monitor, model LC-TWIN, Fetal & maternal monitor models FM-9000, FM-9000Plus, Fetal Monitor, Models FM-3000, Fetal & maternal monitor, models F6, F9, F6 Express & F9 Express, Fetal Monitor, Model:F2,F3, Central Monitoring System model CMS-1000FM and 3 more 2011 6
System, Network And Communication, Physiological Monitors Class 2 MFM-CMS Central Monitoring System, Tecme Central Monitoring System MFM-CMS, Telemetry Monitor Model: iT30, iT50 2024 4
Transducer, Pressure, Intrauterine Class 2 Fetal & maternal monitor, model: F15A, F15A Air 2025 2
Transducer, Ultrasonic, Diagnostic Class 2 Digital Ultrasonic Diagnostic Imaging System models DUS-3000,DUS-3000Plus, Digital Ultrasonic Diagnostic Imaging System models DUS3, DUS 6, UMS 600, P3, Digital Ultrasonic Diagnostic Imaging System DUS60, L-USG-P and 22 more 2009 44
Transducer, Ultrasonic, Obstetric Class 2 Fetal Monitor, model LC-TWIN, Fetal & maternal monitor models FM-9000, FM-9000Plus, Fetal Monitor, Models FM-3000, Fetal & maternal monitor, models F6, F9, F6 Express & F9 Express, Fetal Monitor, Model:F2,F3, Fetal & maternal monitor, model: F15A, F15A Air and 1 more 2011 2
Transmitters And Receivers, Physiological Signal, Radiofrequency Class 2 Patient Monitor LMPLUS-12, LMPLUS-15, LMPLUS-17, MM17, Patient Monitor elite V5, elite V6, elite V8, PM-2000M 15, Patient Monitor Model PM-2000M, Telemetry Transmitter iT20 2016 11
Treadmill, Powered Class 1 TM-400 Treadmill 2009 6
Vectorcardiograph Class 2 Electrocardiograph Model: SE-1202 2021 1

Own-Brand Listings

Devices catalogued by Edan Instruments, Inc.
Product Code Catalogue numbers
ECG cable DSA 73
ultrasonic transducer ITX 70
Electrocardiograph DPS 38
Patient Monitor MHX 22
ECG trunk cable DSA 22
Needle Guide Bracket Kit ITX 21
Ultrasonic Pocket Doppler KNG 20
RespArray ECG whole cable DSA 20
Temperature Probe FLL 18
SpO2 Sensor DQA 17
Diagnostic Ultrasound System IYN 17
NIBP Cuff DXQ 17
Stimulation System IPF 16
Diagnostic Ultrasound System IYO 16
RespArray ECG limb cable DSA 12
ECG limb wires DSA 12
IBP Pressure transducer interface cable DSA 10
NIBP Tube DXQ 10
RespArray NIBP cuff DXQ 9
Digital Ultrasonic Diagnostic Imaging System ITX 9
Vital Signs Monitor DQA 8
Fetal & maternal monitor HGM 8
Monitor, Blood-Flow, Ultrasonic HEP 8
iT20 ECG cable DSA 8
Diagnostic Ultrasound System ITX 8
Monitor, Ultrasonic, Fetal KNG 6
Holter ECG Cable DSA 6
Patient Monitor DQA 6
PC ECG DPS 5
Holter ECG and ABP System DSH 5
ECG Cable DPS 5
Ambulatory Blood Pressure Monitor DXN 5
RespArray Temperature probe FLL 5
RespArray ECG trunk cable DSA 5
Double Chanel IBP Pressure transducer interface cable DSA 5
Pulse Oximeter DQA 5
Ultrasonic TableTop Doppler KNG 4
Oximeter DQA 4
ECG limb cable DSA 4
Ultrasound Transducer HGL 4
Connection Cable IPF 4
UHD series Video Colposcope PTZ 4
Exercise ECG Cable DSA 4
EMG/Stimulation sensor IPF 4
Patient Monitor BZQ 3
Trolley(For medical use) HGM 3
Blood Gas and Electrolyte Control JJS 3
Central Monitoring System HGM 3
US Transducer HGL 3
Test Cartridge CHL 3
Hematocrit Control GLK 2
Holter System MWJ 2
Continuous Measurement Thermometer FLL 2
Toco-Mecg transducer DRT 2
Cardiac output cable DSA 2
ICP transfer cable DSA 2
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK 2
7-pin SpO2 adapter cable DSA 2
Fetal monitor HGM 2
Video Colposcope HEX 2
SE-1202 Series Electrocardiograph DPS 2
Connection Cable DPS 2
Cable, Transducer And Electrode, Patient, (Including Connector) DSA 2
Calibrant Fluid Pack JIX 2
Fetal & Maternal Module HGL 2
Dx12 exercise ECG Cable DSA 2
RespArray MHX 2
Toco Transducer HGL 2
Fetal monitor HGL 2
Vital Signs Monitor DXN 2
Central Monitoring System MHX 2
Adapters DSA 2
RespArray NIBP hose DXQ 2
DX12 ECG cable DRX 1
Treadmill, Powered IOL 1
Vital Signs Monitor MWI 1
Video Colposcope PTZ 1
Transducer, Ultrasonic, Obstetric HGL 1
C.o. Accessories DSA 1
PC ECG (Data Management Software) DPS 1
iT20 SpO2 extension cable DSA 1
Inner press connecting cable HGM 1
System, Monitoring, Perinatal HGM 1
ECG cable DRX 1
Blood Gas and Chemistry Analyzer GLK 1
SpO2 adapter cable, standard (Lemo to DB9) DSA 1
Patient Monitor FLL 1
CO2 Module Extension cable DSA 1
Vital Signs Monitor CCK 1
Patient Monitor DRG 1
SpO2 adapter cable, extended(Lemo to DB9) DSA 1
Patient Monitor DRT 1
Patient Monitor CCL 1
Telemetry Transmitter DRG 1
Fetal Telemetry System HGL 1
H100 SpO2 extension cable DSA 1
Remote Event Marker HGM 1
Dx12 ECG Cable DSA 1
EFM Parameter Module CCK 1
RespArray quick start kit(AHA01) DSA 1
Holter ECG and ABP System DQK 1
Patient Monitor MLD 1
GAS Module Extension cable,0.3m DSA 1
Extension cable for Phasein GAS module DSA 1

Clearances

510(k) clearances naming Edan Instruments, Inc. or its listings
Clearance Decision date Product code Route Held by
K251508 2026-08-06 MHX Traditional This company
K252463 2026-07-02 DPS Traditional This company
K251591 2026-02-09 DQK Traditional This company
K251268 2025-12-23 IYN Traditional This company
K241882 2025-08-27 HGM Traditional This company
K250179 2025-07-29 MHX Traditional This company
K250214 2025-02-20 IYN Traditional This company
K240320 2024-06-28 MHX Traditional This company
K232786 2024-05-16 IPF Traditional This company
K232962 2024-04-19 MHX Traditional This company
K233038 2024-03-08 MWI Traditional This company
K232694 2024-02-05 MHX Traditional This company
K230184 2023-09-25 DSH Traditional This company
K222902 2023-07-28 DPS Traditional This company
K220308 2022-08-11 MHX Traditional This company
K212278 2022-04-07 DPS Traditional This company
K210140 2021-10-01 DPS Traditional This company
K210139 2021-10-01 DXN Traditional This company
K202892 2021-01-28 MWI Traditional This company
K202856 2021-01-25 IYN Traditional This company
K202336 2021-01-23 MHX Traditional This company
K192879 2020-05-21 IYN Traditional This company
K192514 2020-04-02 MHX Traditional This company
K192791 2019-11-27 IYO Traditional This company
K190186 2019-03-28 IYO Traditional This company
K180380 2018-12-21 DQA Traditional This company
K173042 2018-08-30 HGM Traditional This company
K172780 2018-06-06 KNG Traditional This company
K180862 2018-05-24 IYN Traditional This company
K180408 2018-04-13 IYN Special This company
K171942 2018-01-24 DPS Special This company
K173003 2017-11-15 IYN Special This company
K172380 2017-09-29 IYN Traditional This company
K171943 2017-09-25 DPS Traditional This company
K171178 2017-09-06 HGM Traditional This company
K171900 2017-08-18 IYN Traditional This company
K171824 2017-07-18 IYO Traditional This company
K170995 2017-06-02 DPS Traditional This company
K160876 2017-02-15 DPS Traditional This company
K161056 2017-02-03 MHX Traditional This company
K162055 2017-01-31 IYN Traditional This company
K160981 2016-12-22 MHX Traditional This company
K151978 2016-07-15 CHL Traditional This company
K161302 2016-07-01 DPS Traditional This company
K161300 2016-05-31 IYO Special This company
K152552 2016-04-29 MHX Traditional This company
K160790 2016-04-04 IYN Traditional This company
K152427 2016-02-05 DPS Traditional This company
K153475 2016-01-29 KNG Traditional This company
K151787 2016-01-27 DQK Traditional This company
K151878 2015-12-01 HEX Traditional This company
K150901 2015-07-01 HGM Traditional This company
K150999 2015-05-06 IYO Traditional This company
K143695 2015-03-30 HGM Traditional This company
K142511 2015-02-20 IYN Traditional This company
K140579 2015-02-06 KNG Traditional This company
K131971 2014-03-20 MHX Traditional This company
K131503 2014-02-25 DPS Traditional This company
K131819 2013-11-22 DPS Traditional This company
K131830 2013-09-17 IYO Traditional This company
K131818 2013-08-30 DQA Special This company
K120727 2013-06-21 MHX Traditional This company
K123249 2013-02-08 IYN Traditional This company
K122574 2012-10-12 IYO Traditional This company
K120173 2012-05-16 MHX Traditional This company
K120188 2012-03-16 DPS Special This company
K120144 2012-02-14 DXN Special This company
K113653 2012-02-06 MHX Traditional This company
K113623 2012-02-01 MHX Traditional This company
K110922 2011-07-20 MHX Traditional This company
K110999 2011-04-26 ITX Traditional This company
K102140 2011-01-13 HGM Traditional This company
K100358 2011-01-06 HGM Traditional This company
K102835 2010-12-27 DQA Traditional This company
K102854 2010-12-03 DPS Special This company
K102830 2010-12-02 DPS Special This company
K101539 2010-11-24 DQA Traditional This company
K100797 2010-11-10 HGM Traditional This company
K102138 2010-10-28 MAA Traditional This company
K101960 2010-08-10 HEP Special This company
K093869 2010-04-01 DPS Traditional This company
K092727 2009-12-03 DQA Traditional This company
K092997 2009-11-10 KNG Traditional This company
K092010 2009-10-22 DPS Traditional This company
K091513 2009-07-24 DPS Traditional This company
K091680 2009-06-19 ITX Traditional This company
K090367 2009-06-03 DPS Traditional This company
K083821 2009-05-14 DQA Traditional This company
K082602 2008-11-26 HGM Traditional This company
K082369 2008-11-07 HGM Special This company
K080087 2008-03-11 KNG Traditional This company
K073221 2007-12-28 HGM Special This company
K040903 2004-09-02 HGM Traditional This company
K040480 2004-05-25 KNG Traditional This company

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls naming Edan Instruments, Inc.
Initiated FDA class Root cause Reason Quantity Closed
2010-09-10 Not classified Vendor change control The 3 leads of the cable, RL, LA and LL were labeled in wrong sequence. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is mislabeled as left leg (LL). There have bee 615 Ccables 2011-10-13

From the Company

Published by the company on its own website, not by the FDA.

Information published by Edan Instruments, Inc.
Founded 1995
Employees 2700
Main products Ultrasound systems, Patient monitoring devices, In-vitro diagnostics, Point-of-care testing, Diagnostic ECG
Certifications IVDR, ISO standards
Export markets Global

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Shenzhen Hugemed Medical Technical Development Co., Ltd. 22
Allmay Bodywear (Shenzhen) Co., Ltd. 21
Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. 21
Llrn Personal Care (Shenzhen) Co., Ltd. 20
Shenzhen JPY ION-Tech. Co., Ltd. 20
Hochuen Medical Technology Co., Ltd. 20
Hong Qiangxing (Shen Zhen) Electronics Limited 19
Ekong Technology Co., Limited 19
Shenzhen JIE Bishi Technology Co., Ltd. 19
Shenzhen Yhlo Biotech Co., Ltd. 19
Shenzhen Yuwen E-Commerce Co., Ltd. 19
Shenzhen MED-Link Electronics Tech Co., Ltd. 18
Shenzhen Zhouyang Medical Care Product Co., Ltd. 18
Shenzhen Dongdixin Technology Co., Ltd. 18
Vastrade Manufacturing Corporation 18
Ming FAI Industrial (Shenzhen) Co., Ltd. 17
Shenzhen Jie Zhong Lian Technology Co., Ltd. 17
Shenzhen Sunmc Dental Technology Co., Ltd. 17
Shenzhen Kaiyan Medical Equipment Co., Ltd. 17
Shenzhen City U-Lucky Sporting Goods Co., Ltd. 17
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. 17
Shenzhen WAP-Health Technology Co., Ltd. 16
Shenzhen Yimi Care Technology Co., Ltd. 15
Unimed Medical Supplies Inc 15
HongYu BioTech (ShenZhen) Co., Ltd. 15
Shenzhen Moye Technology Co Ltd 14
Shenzhen HLD Dental&Technology Co., Ltd. 14
Shenzhen Obestec Industrial Co., Ltd. 14
Shenzhen Homed Medical Device Co Ltd 13
Shenzhen Yiguangnian Innovation Technology Co., Ltd. 13
Shenzhen Ruiyi Business Technology Co., Ltd. 13
Shenzhen Times Dental LAB 13
Royal Dental Lab 12
Shenzhen Superline Technology Co., Ltd. 12
Shenzhen Rainbow Technology Co., Ltd. 12
Vistar Medical Supplies Co., Ltd. 11
Sunny Medical Device (Shenzhen) Co., Ltd. 11
CBD Dental LAB, Inc 11
Edental LAB Co., Ltd. 11
DTS Digital Dental LAB 11
Medico Technology Co., Ltd. 11
Shenzhen Osto Medical Technology Company Limited 11
Shenzhen Changkun Technology Co., Ltd. 11
Shenzhen Baotonghui Industrial Co., Ltd. 11
KTJ Medical Technology Co., Ltd. 11
Shenzhen Huayan E-Commerce Co., Ltd. 11
Shenzhen Linglu Hongtu Technology Co., Ltd. 11
Shenzhen Golden Wish Personal Care Co., Ltd. 10
Shenzhen Meijiante Technology Co., Ltd. 10
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. 10
Shenzhen Upcera Digital Dental Technology Co., Ltd. 10
Shenzhen Yicai Health Technology Co., Ltd. 10
Shenzhen Weprotex Technology Product Co., Ltd. 10
Taijia Medical Electronics (Shenzhen) Co., Ltd. 10
Shenzhen Insighters Medical Technology Co., Ltd. 10
Hong YU Kang Technology (Guangdong) Co., Ltd. 10
Joydenta Dental Laboratory 10
Shenzhen Youmay Electronics Co., Ltd. 10
Shenzhen Lantise Technology Co., Ltd. 10
Shenzhen Margotan Tech Co., Ltd. 10
Shenzhen Jinyi Medical Technology Co., Ltd. 10
Shenzhen Bway Tech Co., Ltd. 10
Shenzhen Perfect Medical Instruments Co., Ltd. 10
Shenzhen Perfect Idea Technology Limited 10
Shenzhen Willcareyou Technology Co., Ltd. 10
Shenzhen Forever Medical Devices Co., Ltd. 9
Shenzhen Bairunheng Technology Co., Ltd. 9
Shenzhen Viatom Technology Co., Ltd. 9
Shenzhen Ainengke Electronics Co., Ltd. 9
Macrolux Medical Technology Co., Ltd. 9
Shenzhen Create Technology Co., Ltd. 9
AOJ Health Technology Co., Ltd. 9
Shenzhen S-Hande Technology Co., Ltd. 9
GuoLong (Shenzhen) High Technology Co., Ltd. 9
Shenzhen Creative Industry Co., Ltd. 9
Shenzhen Jumper Medical Equipment Co., Ltd. 9
Dakewe(Shenzhen) Medical Equipment Co., Ltd. 9
Shenzhen Sany Pioneer Technology Co., Ltd. 9
Providence Enterprise Limited 9
Shenzhen Lunata Technology Co., Ltd. 9
Shenzhen Samo Technology Co., Limited 9
Shenzhen Relish Technology Co., Ltd. 9
Medcodes Healthcare (Shenzhen) Limited 9
Shenzhen BI-Rich Medical Devices Co., Ltd. 9
Pine Moon Electronics Co., Ltd. 8
Shenzhen Root Innovation Technology Co., Ltd. 8
Siemens Shenzhen Magnetic Resonance Ltd. 8
Shenzhen Konmed Technology Co., Ltd. 8
Shenzhen Caremed Medical Technology Co., Ltd. 8
Shenzhen Launch Electrical Co., Ltd. 8
Respironics Medical Products (Shenzhen) Co., Ltd. 8
Shenzhen Roundwhale Technology Co., Ltd. 8
Shenzhen Coreray Technology Co., Ltd. 8
Shenzhen Rockbrook Daily Products Co., Limited 8
Vivi Dental Laboratory 8
Feellife Health Inc. 8
Bright Dental LAB 8
Simple Medical (Shenzhen) Limited 8
Gymmax Technology Shenzhen Co., Ltd. 8
Shenzhenshi Yifeng Keji Youxian Gongsi 8
NEW Perfect Dental LAB 8
Phase Scientific (Shenzhen) Company Limited 8
Shenzhen Yuechuan Trade Co., Ltd. 8
Shenzhen XFT Medical Limited 8
Shenzhen Zuowei Technology Co., Ltd. 7
Shenzhen Jiahong Dental Technology Co., Ltd. 7
Shenzhen Lescolton Medical Equipment Co., Ltd. 7
Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd 7
Shenzhen Imdk Medical Technology Co., Ltd. 7
League Dental Technology Ltd 7
Sunplus LED Technology Co., Ltd. 7
Sonoscape Medical Corp. 7
Shenzhen Canwin Health Products Co., Ltd. 7
Shenzhen VitaVitro Biotech Co., Ltd. 7
Shenzhen Certainn Technology Co., Ltd. 7
Amedcon Medical Technology (Shenzhen) Co., Ltd. 7
Shenzhen Robust Dental Laboratory Co., Limited 7
Shenzhen Tokyun Technology Co., Ltd. 7
Shenzhen Soga Technology Co., Ltd. 7
Shenzhen Shengbanghua Technology Development Co., Ltd. 7
Shenzhen Xinrun Optical Company Limited 7
Shenzhen Dakewe BIO-Engineering Co., Ltd. 7
Shenzhen AOJ Medical Technology Co., Ltd. 7
Shenzhen Xiangzhida Technology Co., Ltd. 7
Shenzhen Xinzhengyu Technology Co., Ltd. 7
Shenzhen Fox Hunting E-commerce Co., Ltd. 7
Shenzhen Hengdasheng Technology Co., Ltd. 7
Shenzhen Fortunecome Technology Co., Ltd. 7
Shenzhen Micro Electric Intelligence Co., Ltd. 7
Shenzhen Jiding Electronic Co., Ltd. 7
Shenzhen Alex Technology Co., Ltd. 7
Huachenyang(Shenzhen)Technology Co., Ltd. 7
Shenzhen Dahoc Technology Development Co Ltd 7
Shenzhen Mlikang Technology Co., Ltd. 7
Shenzhen Advanced Dental Laboratory 7
Philips Goldway (Shenzhen) Industrial Inc. 7
Shenzhen Desida Technology Co., Ltd. 6
Onbo Electronic (Shenzhen) Co., Ltd. 6
Shenzhen Zowee Smart Manufacturing Co., Ltd. 6
Shenzhen Light Tree Ventures Medical Technology Co., Ltd. 6
Shenzhen Sungpo HI-Tech Electronic Co., Ltd. 6
Shenzhen Pango Medical Electronics Co., Ltd. 6
Unimicro Medical Systems (Shenzhen) Co., Ltd. 6
Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. 6
Grandway Technology (Shenzhen) Limited 6
Shenzhen Shufang Electronic Commerce Co., Ltd. 6
Pengbo (Shenzhen) Medical Technology Co., Ltd. 6
Rejuva Fresh LLC 6
Shenzhen Yongchanghe Technology Co., Ltd. 6
Golden Smile Dental LAB 6
Topway Dental Laboratory Co., Ltd. 6
Shenzhen HYS Medical Co., Ltd. 6
Shenzhen Qianyu Technology Co., Ltd. 6
Macmed Technology Inc. 6
Shenzhen Piocreat 3D Technology Co., Ltd. 6
Shenzhen Hengbosi Industrial Co., Ltd. 6
FOO Tian Dental Laboratory 6
Xemis Medical Technology (Shenzhen) Co., Ltd. 6
Shenzhen Beston E-Commerce Co., Ltd. 6
Shenzhen Ulike Smart Electronics Co., Ltd. 6
Shenzhen Sungrow LED Technology Co., Ltd. 6
Shenzhen Kentro Medical Electronics Co., Ltd. 6
NEW Star Dental LAB Co., Ltd. 6
Carbon (Shenzhen) Medical Device Co., Ltd. 6
Shenzhen Yurucheng Dental Materials Co., Ltd. 6
Shenzhen Upcera Dental Technology Co., Ltd. 6
Shenzhen Jingxintai Houseware Co., Ltd. 6
ADS Dental LAB Ltd. 6
Shenzhen Trious Medical Technology Co., Ltd. 6
Shenzhen Future Electronic Co., Ltd. 6
APK Technology Co., Ltd. 6
Resvent Medical Technology Co., Ltd. 6
Shenzhen Fittop Health Technology Co., Ltd. 6
Shenzhen Besdata Technology Co., Ltd. 6
Shenzhen Chuangxing Optical Co., Ltd. 6
Shenzhen Minghao Dentures Co., Ltd. 6
Konliking Tech & DEV. Limited 6
SHENZhEN Kean Silicone Product Co., Ltd. 6
Jinfeng Import & Export 5
Shenzhen Hongsheng Network Technologyco.,ltd 5
Shenzhen Idea Light Limited 5
Ryder Electronics (Shenzhen) Ltd. 5
Shenzhen Yashiwei Optical Co., Limited 5
Shenzhen Topinnor Technology Co., Ltd. 5
DDS Lab China Co., Ltd. 5
Shenzhen Dongjilian Medical Tech Co., Ltd. 5
Shenzhen Langzhiyin Electronic Co., Ltd. 5
OrbusNeich Medical (Shenzhen) Co., Ltd. 5
Shen Zhen HanShine Technology Co., Ltd. 5
Aikang Medtech Co., Ltd. 5
HUA Cheng XIN Plastic Mold Co., Ltd. 5
Shenzhen Boomingshing Medical Device Co., Ltd. 5
Shenzhen Giftshine Technology Co Ltd 5
Shenzhen Urion Technology Co., Ltd. 5
Shenzhen Aeon Technology Co., Ltd. 5
Flextronics Industrial (Shenzhen) Co., Ltd. 5
Shenzhen Leaflife Technology Co., Ltd. 5
Shenzhen Mindrobot Technology Co., Ltd. 5
Shenzhen Tohachi Industrial Co., Ltd. 5
Shenzhen Changke Connect Electronics Co., Ltd. 5
Meetu Technology (Shenzhen) Co., Ltd. 5
Hayco Industries (Shenzhen) Ltd. 5
Blessing Precisions Technology Shenzhen Company Limited 5
Shenzhen Mondial Technology Co., Ltd. 5
Shenzhen Weijie Intelligent Technology Company Ltd. 5
Shenzhen Delica Medical Equipment Co., Ltd. 5
Shenzhen Baolijie Technology Co., Ltd. 5
Shenzhen Sanping Image Technology Co., Ltd. 5
MediConcepts Technology (Shenzhen) Company Limited 5
Shenzhen GSD Tech Co., Ltd. 5
Shenzhen Aochi Optical Manufactory 5
Shenzhenyuzhuotechnology Co., Ltd. 5
J Mode (Shenzhen) Ltd (Actman Corporation) 5
Aboel Electronic Technology (Shenzhen) Co., Ltd. 5
Shenzhen Nuon Medical Equipment Co., Ltd. 5
Istar Dental LAB 5
CGN Gray (Shenzhen) Technology Co., Ltd. 5
Shenzhen Huiming Optical Co., Ltd. 5
SHL Healthcare Ltd. 5
Shenzhen Lifotronic Technology Co., Ltd. 5
Shenzhen Wanlong Technology Co., Ltd. 4
Nicefeel Medical Device Technology Co., Ltd. 4
Shenzhen Soocas Technology Co., Ltd. 4
S & J Optical (Shenzhen) Ltd. 4
Yuanmeng Chuangzhi Technology(Shenzhen) Co., Ltd. 4
Shenzhen Bona Pharma Technology Co., Ltd. 4
Shenzhen Borria Technology Co., Ltd. 4
Genrui Biotech Inc 4
Shenzhen Baria Technology Co., Ltd. 4
Shenzhen Begood Technology Co., Ltd. 4
Shenzhen Junneeled Technology Co., Ltd. 4
Shenzhen Peninsula Medical Group 4
Shenzhen Airgle Corporation Limited 4
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. 4
Shenzhen Yolanda Technology Co., Ltd. 4
Human Metabolomics Institute, Inc. 4
A&D Electronics (Shenzhen) Co., Ltd. 4
Shenzhen Zhenxing Ruitong Technology Co., Ltd. 4
Shenzhen Aozemei Technology Co., Ltd. 4
Shenzhen Lincond Technology Co., Ltd. 4
Shenzhen Canglv Technology Co., Ltd. 4
Shenzhen Xpectvision Technology Co., Ltd. 4
Shenzhen Moni Technology Co., Ltd. 4
Shenzhen Baojie Optical Co., Ltd. 4
Shenzhen Chuangtong Yigou Technology Co., Ltd. 4
Shenzhen Fitconn Technology Co., Ltd. 4
Shenzhen Sino-K Medical Technology Co., Ltd. 4
Micro-Energy Medical Technology Co., Ltd. 4
Arts Opti LAB (Shenzhen) Company Limited 4
Shenzhen Medke Technology Co., Ltd. 4
Shenzhen Leshang Technology Design Co., Ltd. 4
Shenzhen NEW Industries Biomedical Engineering Co., Ltd. 4
Shenzhen Dartmon Biotechnology Co., Ltd. 4
Shenzhen Wisonic Medical Technology Co., Ltd. 4
Huaqing Glasses (Shenzhen) Company Limited 4
Shenzhen Globow Lighting Technology Co., Ltd. 4
Xiaowe Sound Technology (Shenzhen) Co., Ltd. 4
Eyesberg Optical Limited 4
Shenzhen Crystal-Star Tech Co., Ltd. 4
Shenzhen HGM Glasses Manufacture Co., Ltd. 4
Shenzhen Jiantuo Electronics Co., Ltd. 4
Miraclean Technology Co., Ltd. 4
Tomore Medical (Shenzhen) Co., Ltd. 4
Shenzhen Shanglaite Electronic Technology Co., Ltd. 4
Shenzhen Kesite Digital Technology Co., Ltd. 4
Shenzhen reanson products Co., Ltd. 4
Shenzhen Witleaf Medical Electronics Co., Ltd. 4
Shenzhen Besman Electronic Technology Co., Ltd. 4
Shenzhen Ctlite Technology Co., Ltd. 4
Shenzhen Jermei Medical Device Technology Co., Ltd. 4
Shenzhen Vivolight Medical Device&Technology Co., Ltd. 4
Shenzhen Jianchao Intelligent Technology Co., Ltd. 4
Shenzhen Suyzeko Limited 4
Heifeng Zhizao(Shenzhen)Technology Co., Ltd. 4
Shenzhen Hetaida Technology Limited Company 4
Shenzhen Healthcare Electronic Technology Co., Ltd. 4
Hayco Enterprises (Shenzhen) Ltd. 4
Shenzhen Tonycore Technology Co., Ltd. 4
Shenzhen Allbeauty Technology Co., Ltd. 4
Kinreen Technology(Shenzhen) Co., Ltd. 4
RWD Life Science Co., Ltd. 4
Goodmi Intelligent (Shenzhen) Co., Ltd. 4
Ebulent Optronics (Shenzhen) Ltd 4
Fussen Technology Co., Ltd. 3
Shenzhen Narig BIO-Medical Technology Co., Ltd. 3
ShenZhen GoodlyMed Technology Co., Ltd. 3
Shenzhen Shuge Medical Beauty Devices Co., Ltd. 3
Shenzhen Meihui Optoelectronics Co., Ltd. 3
Aoker Eyewear Manufactory Limited 3
Shenzhen Guangdian Technology Co., Ltd. 3
Shenzhen Combei Technology Co., Ltd. 3
Shenzhen Qianhai Nicemay Medical Beauty Instruments Co., Ltd. 3
Shenzhen Shenrui Medical Co., Ltd. 3
Shenzhen Raycome Health Technology Co., Ltd. 3
Shenzhen Chuanghong Zhilian Technology Co., Ltd. 3
General Meditech, Inc. 3
Shenzhen Brav Electronic Technologies Co., Ltd. 3
Shenzhen Jamr Technology Co., Ltd. 3
Shenzhen Mebao Intelligent Technology Co., Ltd. 3
Shenzhen RedV Medical Equipment Co., Ltd. 3
Shenzhen Contin Medical Device Co., Ltd. 3
Seesun Tech Co., Ltd. 3
Shenzhen Topview Eyewear Industrial Co., Ltd. 3
Bioland Technology Ltd. 3
Octane Eyewear (Shenzhen) Company Limited 3
Grahope New Materials Technologies Inc. 3
Shen Zhen Grace Eyewear Co., Ltd. 3
Lifetech Scientific (Shenzhen) Co,.ltd 3
Shenzhen Ubest Dental Co., Ltd. 3
Shenzhen Ziqing Medical Equipment Co., Ltd. 3
Gimbo Medical Technology Shenzhen Co., Ltd. 3
Bestsea-Tech Limited 3
Gyenno Technologies Co., Ltd. 3
Shenzhen Sophway Technology Co., Ltd. 3
Icare Liboxy Optical (Shenzhen) Ltd. 3
Shenzhen Youyou Technology Co., Ltd. 3
Shenzhen Qinglai Innovative Intelligent Technology Co., Ltd. 3
Monde Dental LAB 3
Kunwei Medical Electronics Co., Ltd. 3
Shen Zhen DE YI SHI Glasses Ltd 3
Advance Technology Ltd 3
Shenzhen Huayu Wantuo Technology Co., Ltd. 3
Shenzhen Dachi Communication Co., Ltd. 3
Shenzhen Comfort Technology Co., Ltd. 3
Shenzhen Oushirui Trading Co., Ltd. 3
Shenzhen Kingboom Technology Co., Ltd. 3
Shenzhen Zhengkang Technology Co., Ltd. 3
Shenzhen Risun Technology Co., Ltd. 3
Shenzhen Byring Hearing Technology Co., Ltd. 3
Arttech International Limited 3
FGX International Limited – China 3
Shenzhen Hexin Zondan Medical Equipment Co., Ltd. 3
Shenzhen Xilang E-Commerce Co., Ltd. 3
Shenzhen Finicare Co., Ltd. 3
Shenzhen Flysounds Medical Technology Co., Ltd. 3
Shenzhen Sinco Technology Co., Limited 3
Twinklers Limited 3
Shenzhen Jimei Technology Development Co., Ltd. 3
Shenzhen Yadi Optical Manufactory Company Limited 3
Sunglor Technology Co., Ltd. 3
Bestway Optical Co., Limited 3
Solaris Medical Technology, Inc. 3
Shenzhen Caidisen Optoelectronics Co., Ltd. 3
Shenzhen Yiran Intelligent Co., Ltd. 3
Shenzhen Yingchi Technology Co., Ltd. 3
Risun Technology (Shenzhen) Limited 3
Shenzhen Dazhou Medical Technology Co., Ltd. 3
Longview Optical (Shenzhen) Company Limited 3
Shenzhen Huihong Eyewear Technology Co., Ltd. 3
Ziree (Shenzhen) Medical Technology Co., Ltd. 3
Shenzhen Azure Technology Co., Ltd. 3
Shenzhen Sunsred Technology Co., Ltd. 3
Jiale Health Technology Shenzhen Co., Ltd. 3
Pak Mane Plastic And Metal (Shen Zhen) Company Limited 3
Shenzhen Yunding Information Technology Co., Ltd. 3
Shenzhen Zhongde Audio-Technical Co., Ltd. 3
Shenzhen TPH Technology Co., Ltd. 2
Eran Technology (Shenzhen)Co., Limited 2
Shenzhen Zhimahuaerkai Technology Co., Ltd. 2
Shenzhen Century Dongyuan Technology Co., Ltd. 2
Eagle Electric(Shenzhen) Co., Ltd. 2
MedHealth Medical Limited 2
Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. 2
Lifemotion Medical Technology Co., Ltd. 2
Shenzhen RF Tech Co., Ltd. 2
Coriton Instrument Co., Ltd. 2
Hongchuangda Glasses Technology Shenzhen Co Ltd 2
Rayneo Co., Ltd. 2
Shenzhen Codyson Electrical Co., Ltd. 2
Shenzhen Yimi Life Technology Co., Ltd. 2
Shenzhen Yuechi Innovation Technology Co., Ltd. 2
Shenzhen Life-King Technology Co., Ltd. 2
Alicn Medical Shenzhen, Inc 2
Shenzhen Everbest Machinery Industry Co Ltd 2
Shenzhen Shenbo Energy Manufacturing Co., Ltd. 2
Golden Star Optical (ShenZhen) Limited 2
Shenzhen LYA Silicone Rubber Products Co., Ltd. 2
IBE Electronics Co., Ltd. 2
Shenzhen Trendz Technology Co., Ltd. 2
Shenzhen Goldcare Meditech Co., Ltd. 2
Xinkang Medical Instrument Co., Ltd. 2
Shenzhen Rongfeng Technology Co., Ltd. 2
Daichuan Medical (Shenzhen) Co., Ltd. 2
Palconn Technology Co., Ltd. 2
Shenzhen Visbody Intelligent Technology Co., Ltd. 2
Shenzhen Endless Industrial Development Co., Ltd. 2
Shenzhen Junjiada Electric Appliance Co., Ltd. 2
Shenzhen Sinrel Tech Ltd 2
Shenzhen Wonderful Gift Technology Co., Ltd. 2
Shenzhen Breo Technology Co., Ltd. 2
Shenzhen Kingho Technology Co., Ltd. 2
Shenzhen Biocare Bio-Medical Equipment Co., Ltd. 2
Shenzhen H&T Intelligent Control Co., Ltd. 2
Shenzhen Hanasco Technology Co., Ltd. 2
Masep Medical Science & Technology DEVELOPMENT(SHENZHEN)Co. 2
Shenzhen Sunsmile International Trading Ltd. 2
Toparc Technology (Shenzhen) Co., Ltd. 2
Shenzhen Watmind Medical Co., Ltd. 2
Even Realities Ltd. 2
Shenzhen Yashunmei Technology Co., Ltd. 2
Shen Zhen Colden Star Ptical Co., Ltd. 2
Shenzhen Envision Technology Innovation Co., Ltd. 2
Boynee Underwear (S.Z) Co., Ltd. 2
Cha’s Electronic Industries (Shenzhen) Company Limited 2
Shenzhen Minghuangda Electronics Co., Ltd. 2
Shenzhen Kenvox Technology Co., Ltd. 2
Shuhai Jingwei(Shenzhen) Information Technology Co., Ltd. 2
Shenzhen NOE Optical Co., Ltd. 2
Shimeng Industrial (Shenzhen) Co., Ltd. 2
Iconbeauty (Shenzhen) Holding Ltd. 2
Shenzhen Fansizhe Science AND Technology Co., Ltd. 2
Elehear Inc. 2
Shenzhen Yamada Electric Co., Ltd. 2
Shenzhen Woodpecker Technology Co., Ltd. 2
Zhongrui HearJoy Medical Equipment Co., Ltd. 2
Shenzhen Ruiankang Technology Co., Ltd. 2
E-Business International Inc. 2
Shen Zhen Shang Shen Optical Manufacture Co., Ltd. 2
Shenzhen Tengfei YU Technology Co., Ltd. 2
Shenzhen Gnda Optical Co., Ltd. 2
Shenzhen Ruizhang Industrial Co., Ltd. 2
Winner Medical Co., Ltd., Shenzhen Branch 2
Mehow Innovative Ltd 2
Yilian Yike (Shenzhen) Technology Co., Ltd. 2
Laserpair Co., Limited 2
Atop Lighting Co., Ltd. 2
Hang Yik Electronics Plastics & Mold (ShenZhen) Co., Ltd. 2
Shenzhen Hanhua Opto Co., Ltd. 2
Shenzhen Junyuan Medical Equipment Co., Ltd. 2
Shenzhen Eartech Company Ltd. 2
Shenzhen Ivankaca Technology Co., Ltd. 2
Shenzhen Haiyongyu Technology Co., Ltd. 2
Shenzhen Beacon Display Technology Co., Ltd. 2
Shenzhen Well Electric Co., Limited 2
Shenzhen Redy-MED Technology Co., Ltd. 2
Shenzhen Libai Technology Co., Ltd. 2
Shenzhen Dongjiang Technology Co., Ltd. 2
Shenzhen Hanchuan Industrial Co., Ltd. 2
Shenzhen Gwode Technology Co., Ltd. 2
Shenzhen Kizoku Life Technology Co., Ltd. 2
Shenzhen Jian Feng Electronic Technology Co., Ltd. 2
Shenzhen Baichang Technology Co., Ltd. 2
Shenzhen Carewell Electronics Co., Ltd. 2
Shenzhen Taikang Medical Equipment Co., Ltd. 2
Shenzhen Wellcore Well Technology Co., Ltd. 2
Shenzhen Weizhilichuang Technology Co., Ltd. 2
Shenzhen Bonliter Optoelectronic Co., Ltd. 2
Suntech Medical Devices (Shenzhen) Co., Ltd. 2
Shenzhen Harveymed Technology Co., Ltd. 2
Astrasono Technology Co., Ltd. 2
Shenzhen Dashicheng Optical Technology Co., Ltd. 2
Shenzhen Zhuoshang Optical Company Limited 2
Shenzhen Unique Scales Co., Ltd. 2
Shenzhen Superlife Industrial Limited 2
Shenzhen Shine Industrial Co., Ltd. 2
Shenzhen Rainbow Light Medical Equipment Co., Ltd. 2
Shenzhen UP3D Tech Co., Ltd. 2
Athena Innovation (Shenzhen) Technology Co., Ltd. 2
Shenzhen Sight World Optical Limited 2
SZ KKS Silicone&Electronic Co., Ltd. 2
Ortus Medi-Tech Co., Ltd. 2
Shenzhen Pinchuan Vision Health Technology Co., Ltd. 1
Shenzhen Tsingyan Health Technology Co., Ltd. 1
Shenzhen Hingmed Medical Instrument Co., Ltd. 1
Cosmo FAR East Technology Limited 1
Shenzhen Prunus Medical Co., Ltd. 1
Shenzhen THE World OF Chamerlain Trade Lmport AND Export Co., Ltd. 1
Shenzhen Tsyl General Technology Ltd. 1
Shenzhen Yihong Lighting Co., Ltd. 1
Shenzhen Fuzhongkang Technology Co., Ltd. 1
Shenzhen Shengye Technology Co., Ltd. 1
Shenzhen Saidi Light Therapy Technology Co., Ltd. 1
Shenzhen Akaudio Co., Limited 1
E.shine Systems Limited 1
Shenzhen Hanhan Technology Co., Ltd. 1
Shenzhen Cannice Technology Co., Ltd. 1
Shenzhen Apom Optical Technology Co., Ltd. 1
Shenzhen Shuhe Technology Co., Ltd. 1
Shenzhen Ionka Medical Technology Co., Ltd. 1
Shenzhen Huachuangtong Industrial Co., Ltd. 1
Shenzhen Boon Medical Supply Co., Ltd. 1
Polyrack Science & Technology Co., Ltd. 1
Shenzhen Sponge NEW Material Co., Ltd. 1
Shenzhen Auraluxe Medical Equipment Co., Ltd. 1
Shenzhen Mareal Tech Co., Ltd. 1
Shenzhen Yang WO Electronic Co., Ltd. 1
Shenzhen Mezans Technology Co., Ltd. 1
Shenzhen Foamtech Co., Ltd. 1
Shenzhen Enhanced Power Technology Co., Ltd. 1
Shenzhen Aspiron Technology Company Limited 1
Shenzhen Fengzhaowei Technology Co., Ltd. 1
Shenzhen Calison Technology Co., Limited 1
Shenzhen Meirui Shangpin Technology Co., Ltd. 1
Estone Technology Ltd 1
Shenzhen Jovs Technology Co., Ltd. 1
Shenzhen Yang Biotech Co., Ltd. 1
Shenzhen Mlay Intelligent Technology Co., Ltd. 1
Shenzhen Jinzhou Precision Technology Corp. 1
Shenzhen Qiaochengli Technology Co., Ltd. 1
Lasxbot (Shenzhen) Robot Co., Ltd. 1
Beame Medical Technology (Shenzhen) Limited 1
Shenzhen Kingod Silicone Rubber Products Co., Ltd. 1
Shenzhen Sinoco Medical Equipment Co., Ltd. 1
EG-Medacys Devices(Shenzhen)Co., Ltd. 1
Shenzhen JVK Medical Instruments Co., Ltd. 1
Remax Medi-Tech(Shenzhen) Corporation 1
Shenzhen Huaruibo Electric Appliances Co., Ltd. 1
Shenzhen Cosinno Technology Co., Ltd. 1
Shenzhen EL3IMAGING Medical Devices Co., Ltd. 1
Medcaptain Medical Technology Co., Ltd. 1
Omould Technology China Co Ltd 1
Union Medical Shenzhen Co., Ltd. 1
Biomol Light Limited 1
Shen Zhen SHI FAN FEN SHU Technology Co., Ltd. 1
Shenzhen Zhongyi Technology Co., Ltd. 1
Jingfang Precision Medical Device(Shenzhen) Co., Ltd. 1
Shenzhen Zhixin Biomedical Technology Co., Ltd. 1
Shenzhen Semlamp Intelligent Technology Co., Ltd. 1
Shenzhen Yattll Industry Co., Ltd. 1
Freudenberg Medical Plastic & Metal Manufacturing (Shenzhen) Co., Ltd. 1
Fly Cat Electrical Co., Ltd. 1
Shenzhen Hongqin Mold Co., Ltd. 1
Shenzhen AIS Queen Medical Technology Co., Ltd. 1
Shenzhen Bestman Instrument Co., Ltd. 1
Grandee Electric Appliance (Shenzhen) Limited 1
Vita Tesco 1
Mustech Electronics Co., Limited 1
Gmdasz Manufacturing Co., Ltd. 1
Shenzhen Ishine Technology Company Limited 1
Shen Zhen Great Force Plastic Products Co., Ltd. 1
Shenzhen Gel Word Medical Devices Co., Ltd. 1
Shenzhen SOG Intelligent Technology Co., Ltd. 1
Shenzhen Omori Biological Technology Co., Ltd. 1
Ruichuangke Digital Co., Ltd. 1
Shenzhen Yishili Beauty Technology Co., Ltd. 1
Vvfly Electronics Co., Ltd. 1
Shenzhen Deliduo Medical Technology Co., Ltd. 1
Shenzhen Zhiqi Technology Co., Ltd. 1
Shenzhen Tuyou Medical Imaging Co., Ltd. 1
Aidite (Shenzhen) Medical Technology Co., Ltd. 1
Flextronics Medical Molding (Shenzhen) Co., Ltd. 1
Shenzhen Anshichuangyi Technology Co., Ltd. 1
Shenzhen Oceanus Medical Device Co., Ltd. 1
Shenzhen Benxiang Optoelectronic Co., Ltd. 1
Shenzhen Intra Industry DBA SBI Smart Brands International [america] 1
Hongguang Biophototherapy Technology (Shenzhen) Co., Ltd. 1
Shenzhen Kingbrite Lighting Co., Ltd. 1
Shenzhen Xingyi Intelligent Technology Co., Ltd. 1
Yiwei Medical Technology Co., Ltd. 1
Shenzhen Saiote Intelligent Manufacturing Co., Ltd. 1
ONE Beauty Technology Co., Ltd. 1
Shenzhen Vital Signs-KTL Medical Instrument Co Ltd 1
Shenzhen Shuichang Technology Co., Ltd. 1
Shenzhen Jian Health Technology Co., Ltd. 1
Shenzhen Upnmed Equipment Co., Ltd. 1
Pndus Biotechnology (Shenzhen) Company, Ltd 1
Shenzhenshiaixulikejiyouxiangongsi 1
menovex Medical Technology (Shenzhen) Co., Ltd. 1
Entech Electronics Trade (Shenzhen) Company Ltd. 1
Shenzhen Yuxinyuan Electronic Technology Co., Ltd. 1
Shenzhen MEI ZHI Guang Dian Limited 1
Shenzhen V-Intelligence Technology Limited 1
Shenzhen Envisen Industry Co., Ltd. 1
BestNews Electronic Ware(S.Z) Co., Ltd. 1
Hitrons Intelligence (Shenzhen) Limited 1
Shenzhen Gonbes Technology Co., Ltd. 1
Shenzhen Shengzhou Intelligent Equipment R&D Co., Ltd. 1
Shenzhen Baofengtong Electrical Appliances Manufacturing Co., Ltd. 1
Shenzhen Jizhimei Technology Co., Ltd. 1
Shenzhen Fenda Technology Co., Ltd. 1
Vascupatent Medical (Shenzhen) Co., Ltd. 1
Shenzhen Wikkon Precision Technologies Co., Ltd. 1
Shenzhen Forrest Health Technology Co., Ltd. 1
Shenzhen Hongkexun Electronics Technology Co., Ltd. 1
Shenzhen Tengda Zhichuang Technology Co., Ltd. 1
Shen Jia Yi Optical (Shenzhen) Ltd 1
Shenzhen Yinghuada Technology Co., Ltd. 1
Shenzhen Calibeur Industries Co., Ltd. 1
Talent Technology Mould Co., Limited 1
Shenzhen Ifree Electronics Limited 1
Weony (Shenzhen) Technology Co., Ltd. 1
Shenzhen Juzhong Technology Co., Ltd. 1
Shenzhen Lilian Precision Mould Manufacturing Co., Ltd. 1
J. B. Health Technology (Shenzhen) Co Ltd 1
Shenzhen Sounds Good Technologies Co., Ltd. 1
Shenzhen Ilux Technology Co., Ltd. 1
Shenzhen Marlin E-Commerce Technology Co., Ltd. 1
Shenzhen Hetailai Technology Co., Ltd. 1
Shenzhen 3NOD Digital Technology Co., Ltd. 1
Shenzhen Cresendo Technology Co., Ltd. 1
Powerfirst Technology Company Limited 1
Shenzhen Leading Technology Co., Ltd. 1
Shenzhen Kangbaote Electronics Co., Ltd. 1
Shenzhen Andy Photoelectric Technology Co., Ltd. 1
Vcomin Technology Limited 1
Glpe Medical Device Co., Ltd. 1
Shenzhen Ranvoo Digital Technology Co., Ltd. 1
Shenzhen Xinrun Electric Appliances Co Ltd 1
Shenzhen Kaduo Industrial Co., Ltd. 1
Shenzhen Gangyu Technology Co., Ltd. 1
Flexible Circuit Technologies Shenzhen 1
Shenzhen Lensgoo Vision Co., Ltd. 1
Shenzhen Hongzhun Zhizao Technology Co., Ltd. 1
Shenzhen Allwell Sports Products Manufacturing Co., Ltd. 1
Shenzhen Bestpad Technology Development Co., Ltd. 1
Blue Deer Medical Equipment (Guangdong) Co., Ltd. 1
Fussen Imaging Co., Ltd. 1
Enlight Medical Technologies (Shenzhen) Co., Ltd. 1
Shenzhen HS Medical Equipment Co., Ltd. 1
Shenzhen Cnuo Electronics Co., Ltd. 1
Johnny Vico Infant & Gift Products (China )Co., Ltd. 1
Sunstar Digi (H.K.) Co., Ltd. 1
Shenzhen Yuanhua Medical Equipment Technology Co., Ltd. 1
Tontec Precision Plastics Technology (Shenzhen) Co., Ltd. 1
Shenzhen Yuwei Electronic Technology Co., Ltd. 1
Shenzhen Iboolo Optics Co., Ltd. 1
Shenzhen Youlumi Co., Ltd. 1
Shenzhen Enmind Technology Co., Ltd. 1
Shenzhen Vitared Technology Co., Ltd. 1
Shenzhen Jinlichang Electronic Technology Co., Ltd. 1
Shenzhen Lizbella Technology Co., Ltd. 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer