Shenzhen Mindray BIO-Medical Electronics Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 61 device types, 1,329 products catalogued, 160 clearances.
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Oximeter, Detergent and 59 other device types. 300 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009156722 |
| FEI number | 3009156722 |
| DUNS | 654671304 |
| Establishment type | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳迈瑞生物医疗电子股份有限公司 |
|---|---|
| Unified social credit code | 914403007084678371 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 1203 Nanhuan Avenue |
| Postal code | 518106 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Alarm, Blood-Pressure | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C), BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU) and 8 more | 2018 | 7 |
| Amplifier And Signal Conditioner, Transducer Signal | Class 2 | BeneVision Central Monitoring System, BeneVision Central Monitoring System(BeneVision/ TMS-6016/Telepack-608/TMS60/TM80/TM70) | 2017 | 4 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Class 1 | BS-800M,ABS800,BA-800M ISE KIT,BS-800M Chemistry Analyzer,BA-800M Chemistry Analyzer,ABS-800 Chemistry Analyzer, BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720i Chemistry Analyzer, BA-480 Chemistry Analyzer, Yumizen C560 Chemistry Analyzer and 2 more | 2008 | 16 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12, A8, A9 Anesthesia System, Anesthesia System(A5,A7,A4) and 25 more | 2013 | 29 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | A8, A9 Anesthesia System, Anesthesia System(A5,A7,A4), V Series Monitoring System, BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C) and 12 more | 2013 | 5 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12, A8, A9 Anesthesia System, Anesthesia System(A5,A7,A4) and 16 more | 2013 | 6 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12, A8, A9 Anesthesia System, Anesthesia System(A5,A7,A4) and 16 more | 2013 | 6 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | A8, A9 Anesthesia System, Anesthesia System(A5,A7,A4), V Series Monitoring System, BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C) and 12 more | 2013 | 5 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12, A8, A9 Anesthesia System, Anesthesia System(A5,A7,A4) and 16 more | 2013 | 6 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12, Anesthesia System(A5,A7,A4), V Series Monitoring System and 15 more | 2013 | 8 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | A8, A9 Anesthesia System, Anesthesia System(A5,A7,A4), V Series Monitoring System, BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C) and 12 more | 2013 | 5 |
| Burst Suppression Detection Software For Electroencephalograph | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Anesthesia System(A5,A7,A4), BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C) and 7 more | 2022 | 3 |
| Calibrator For Cell Indices | Class 2 | SC-CAL Plus Calibrator | 2016 | 3 |
| Calibrator For Hemoglobin And Hematocrit Measurement | Class 2 | SC-CAL Plus Calibrator | 2016 | 2 |
| Calibrator For Platelet Counting | Class 2 | SC-CAL Plus Calibrator | 2016 | 2 |
| Calibrator For Red-Cell And White-Cell Counting | Class 2 | SC-CAL Plus Calibrator | 2016 | 2 |
| Computer, Blood-Pressure | Class 2 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1), ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12, BeneVision N Series Patient Monitor (BeneVision N12, BeneVision N15, BeneVision N17 ) and 20 more | 2014 | 12 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12, V Series Monitoring System, BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo) and 11 more | 2014 | 5 |
| Computer, Diagnostic, Programmable | Class 2 | V Series Monitoring System | 2014 | 10 |
| Continuous Measurement Thermometer | Class 2 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1), ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12, BeneVision N Series Patient Monitor (BeneVision N12, BeneVision N15, BeneVision N17 ) and 29 more | 2014 | 115 |
| Counter, Differential Cell | Class 2 | BC-3200 Auto Hematology Analyzer, BC-3600 Auto Hematology Analyzer, BC-5390 Auto Hematology Analyzer | 2010 | 3 |
| Detector And Alarm, Arrhythmia | Class 2 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1), ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12, BeneVision N Series Patient Monitor (BeneVision N12, BeneVision N15, BeneVision N17 ) and 20 more | 2014 | 10 |
| Detergent | Class 1 | M-30 E-Z Cleanser, Probe Cleanser, CD 80 Detergent, M-30P Probe Cleanser, Wash Solution, M-30R Rinse | 2012 | 5 |
| Device, Monitoring, Intracranial Pressure | Class 2 | V Series Monitoring System | 2014 | 5 |
| Diluent, Blood Cell | Class 1 | M-30D DILUENT,M-53D Diluent | 2011 | 5 |
| Electrode, Cutaneous | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C), BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU) and 6 more | 2022 | 47 |
| Electrode, Ion Specific, Potassium | Class 2 | BS-800M,ABS800,BA-800M ISE KIT,BS-800M Chemistry Analyzer,BA-800M Chemistry Analyzer,ABS-800 Chemistry Analyzer, BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720i Chemistry Analyzer, BA-480 Chemistry Analyzer, Yumizen C560 Chemistry Analyzer and 2 more | 2008 | 2 |
| Electrode, Ion Specific, Sodium | Class 2 | BS-800M,ABS800,BA-800M ISE KIT,BS-800M Chemistry Analyzer,BA-800M Chemistry Analyzer,ABS-800 Chemistry Analyzer, BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720i Chemistry Analyzer, BA-480 Chemistry Analyzer, Yumizen C560 Chemistry Analyzer and 2 more | 2008 | 2 |
| Electrode, Ion-Specific, Chloride | Class 2 | BS-800M,ABS800,BA-800M ISE KIT,BS-800M Chemistry Analyzer,BA-800M Chemistry Analyzer,ABS-800 Chemistry Analyzer, BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720i Chemistry Analyzer, BA-480 Chemistry Analyzer, Yumizen C560 Chemistry Analyzer and 2 more | 2008 | 2 |
| Gas-Machine, Anesthesia | Class 2 | A8, A9 Anesthesia System, Anesthesia System(A5,A7,A4), A7 Anesthesia System, A5 Anesthesia System, A4 Anesthesia System, A3 Anesthesia Delivery System and 1 more | 2013 | 4 |
| Hexokinase, Glucose | Class 2 | BS-400/CLC 720 Chemistry Analyzer, BS-200 Chemistry Analyzer,Pointe c2000 Chemistry Analyzer | 2008 | 2 |
| Index-Generating Electroencephalograph Software | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Anesthesia System(A5,A7,A4), BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C) and 7 more | 2022 | 4 |
| Mixture, Hematology Quality Control | Class 2 | BC-5D hematology control, BC-3D CONTROL (Low, Normal and High) | 2011 | 3 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Class 2 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1), BeneVision Central Monitoring System, ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12 and 22 more | 2014 | 9 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class 2 | VS Series Vital Signs Monitors (Including VS 9/VS 8/VS 8A), Accutorr 3,VS-600 Vital Signs Monitor, Rosebud VC, Accutorr 7,VS-900 Vital Signs Monitor, Rosie 4, Vital Signs Monitors(Including VS 9, VS 8, VS 8A) and 7 more | 2014 | 17 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Class 2 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1), Passport Series Patient Monitors (T1), BeneVision Central Monitoring System, ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8 and 29 more | 2014 | 9 |
| Monitor, St Segment | Class 2 | BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C), BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU), BeneVision N Series Patient Monitors (Including BeneVision M19 , BeneVision M19C , BeneVision M17), BeneVision N Series Patient Monitors (Including BeneVision N15 ICU, BeneVision N15 OR, BeneVision N15 Neo) and 4 more | 2022 | 2 |
| Monitor, St Segment With Alarm | Class 2 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1), ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12, BeneVision N Series Patient Monitor (BeneVision N12, BeneVision N15, BeneVision N17 ) and 20 more | 2014 | 7 |
| Non-Normalizing Quantitative Electroencephalograph Software | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Anesthesia System(A5,A7,A4), BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C) and 7 more | 2022 | 3 |
| Oximeter | Class 2 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1), BeneVision Central Monitoring System, ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12 and 31 more | 2014 | 70 |
| Oximeter, Ear | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12 | 2014 | 4 |
| Oximeter, Tissue Saturation | Class 2 | V Series Monitoring System, BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C), BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU), BeneVision N Series Patient Monitors (Including BeneVision M19 , BeneVision M19C , BeneVision M17) and 5 more | 2014 | 5 |
| Plethysmograph, Impedance | Class 2 | BeneVision Central Monitoring System, BeneVision Central Monitoring System(BeneVision/ TMS-6016/Telepack-608/TMS60/TM80/TM70), BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C), BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU) and 6 more | 2019 | 5 |
| Products, Red-Cell Lysing Products | Class 1 | M-30CFL Lyse, M-5LEO(I) Lyse, M-5LEO(II) Lyse, M-53LH Lyse | 2011 | 3 |
| Reduced- Montage Standard Electroencephalograph | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Anesthesia System(A5,A7,A4), BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C) and 7 more | 2022 | 3 |
| Regulator, Vacuum | Class 2 | A8, A9 Anesthesia System, A7 Anesthesia System | 2018 | 4 |
| Spirometer, Monitoring (W/Wo Alarm) | Class 2 | Gas Module 3 | 2019 | 5 |
| Stimulator, Nerve, Peripheral, Electric | Class 2 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Anesthesia System(A5,A7,A4), BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C) and 7 more | 2022 | 5 |
| Sv70 Ventilator | Class 2 | SV70 Ventilator (SV70) | 2026 | 4 |
| System, Image Processing, Radiological | Class 2 | DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System, DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System, Recho R9W, Recho R9, Recho R9 Pro, Recho R9 Exp, Recho R9S, Recho R9T Diagnostic Ultrasound System, Crius R9 CV, Anesus R9 CV, Recho R9 Super, Recho R9 Lumi, Recho R CV, Recho R CVx Diagnostic Ultrasound System, DC-8,DC-8 PRO,DC-8 CV,DC-8 EXP,DC-8S Diagnostic Ultrasound System, DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System and 3 more | 2017 | 16 |
| System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System, DC-41/DC-42/DC-40T/ DC-33/DC-36/DC-38/DC-39 Diagnostic Ultrasound System, Nuewa R9/Nuewa R9 Exp/Nuewa R9 Pro/Nuewa R9S Diagnostic Ultrasound System, Resona 7/Resona 7CV/Resona 7EXP/Resona 7S Diagnostic Ultrasound Syste, Resona 7OB/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System, Resona R9/Resona R9 Exp/Resona R9 Pro/Resona R9S Diagnostic Ultrasound System and 131 more | 2010 | 22 |
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System, DC-41/DC-42/DC-40T/ DC-33/DC-36/DC-38/DC-39 Diagnostic Ultrasound System, Nuewa R9/Nuewa R9 Exp/Nuewa R9 Pro/Nuewa R9S Diagnostic Ultrasound System, Resona 7/Resona 7CV/Resona 7EXP/Resona 7S Diagnostic Ultrasound Syste, Resona 7OB/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System, Resona R9/Resona R9 Exp/Resona R9 Pro/Resona R9S Diagnostic Ultrasound System and 133 more | 2009 | 37 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1), BeneVision Central Monitoring System, ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ), ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Passport 8, Passport 12 and 31 more | 2014 | 98 |
| System, Network And Communication, Physiological Monitors | Class 2 | BeneVision Central Monitoring System, BeneVision Central Monitoring System(BeneVision/ TMS-6016/Telepack-608/TMS60/TM80/TM70), BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C), BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU) and 6 more | 2015 | 4 |
| Tester, Electrode, Surface, Electrocardiographic | Class 2 | BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C), BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU), BeneVision N Series Patient Monitors (Including BeneVision M19 , BeneVision M19C , BeneVision M17), BeneVision N Series Patient Monitors (Including BeneVision N15 ICU, BeneVision N15 OR, BeneVision N15 Neo) and 4 more | 2022 | 2 |
| Transducer, Blood-Pressure, Extravascular | Class 2 | BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C), BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU), BeneVision N Series Patient Monitors (Including BeneVision M19 , BeneVision M19C , BeneVision M17), BeneVision N Series Patient Monitors (Including BeneVision N15 ICU, BeneVision N15 OR, BeneVision N15 Neo) and 5 more | 2018 | 7 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System, DC-41/DC-42/DC-40T/ DC-33/DC-36/DC-38/DC-39 Diagnostic Ultrasound System, Nuewa R9/Nuewa R9 Exp/Nuewa R9 Pro/Nuewa R9S Diagnostic Ultrasound System, Resona 7/Resona 7CV/Resona 7EXP/Resona 7S Diagnostic Ultrasound Syste, Resona 7OB/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System, Resona R9/Resona R9 Exp/Resona R9 Pro/Resona R9S Diagnostic Ultrasound System and 133 more | 2009 | 44 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Class 2 | BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo), BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo), BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C), BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU), BeneVision N Series Patient Monitors (Including BeneVision M19 , BeneVision M19C , BeneVision M17), BeneVision N Series Patient Monitors (Including BeneVision N15 ICU, BeneVision N15 OR, BeneVision N15 Neo) and 4 more | 2022 | 11 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | Class 2 | BS-800M,ABS800,BA-800M ISE KIT,BS-800M Chemistry Analyzer,BA-800M Chemistry Analyzer,ABS-800 Chemistry Analyzer, BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720i Chemistry Analyzer, BA-480 Chemistry Analyzer, Yumizen C560 Chemistry Analyzer | 2014 | 1 |
| Vaporizer, Anesthesia, Non-Heated | Class 2 | Drager Vapor 2000 SERVO and Vapor 2000 ISO, V80 Anesthetic Vaporizer, Drager D-Vap DES, V60 Anesthetic Vaporizer | 2015 | 1 |
| Ventilator, Continuous, Facility Use | Class 2 | Ventilator(SV600,SV800,SV700,SV900), Mindray SV600 Ventilator, Mindray SV800 Ventilator | 2024 | 8 |
Own-Brand Listings
Showing 250 of 300 products listed by this company.
Clearances
160 clearances name Shenzhen Mindray BIO-Medical Electronics Co., Ltd. as applicant. 22 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253330 | 2026-06-25 | BSZ | Traditional | This company |
| K260098 | 2026-05-20 | MHX | Traditional | This company |
| K260846 | 2026-05-11 | IYN | Traditional | This company |
| K253170 | 2026-04-16 | MHX | Traditional | This company |
| K252182 | 2026-04-06 | MNT | Traditional | This company |
| K253049 | 2026-02-11 | IYN | Traditional | This company |
| K251601 | 2025-12-03 | IYN | Traditional | This company |
| K251853 | 2025-11-07 | IYN | Traditional | This company |
| K251820 | 2025-09-12 | IYN | Traditional | This company |
| K251250 | 2025-09-05 | IYN | Traditional | This company |
| K243767 | 2025-08-28 | CBK | Traditional | This company |
| K251192 | 2025-08-22 | IYN | Traditional | This company |
| K242728 | 2025-07-31 | MSX | Traditional | This company |
| K250024 | 2025-05-30 | IYN | Traditional | This company |
| K250020 | 2025-05-19 | IYN | Traditional | This company |
| K250110 | 2025-05-16 | IYN | Traditional | This company |
| K242231 | 2024-11-08 | IYN | Traditional | This company |
| K240375 | 2024-10-31 | CAD | Traditional | This company |
| K241201 | 2024-09-16 | IYN | Traditional | This company |
| K241432 | 2024-09-12 | IYN | Traditional | This company |
| K240906 | 2024-07-23 | IYN | Traditional | This company |
| K240684 | 2024-06-17 | IYN | Traditional | This company |
| K240115 | 2024-04-22 | IYN | Traditional | This company |
| K231685 | 2023-10-26 | IYN | Traditional | This company |
| K220107 | 2023-06-16 | CBK | Traditional | This company |
| K230768 | 2023-06-09 | IYN | Traditional | This company |
| K222928 | 2023-02-07 | IYN | Traditional | This company |
| K221113 | 2022-12-02 | MWI | Traditional | This company |
| K221300 | 2022-09-29 | IYN | Traditional | This company |
| K221496 | 2022-09-29 | IYN | Traditional | This company |
| K213799 | 2022-07-12 | MHX | Traditional | This company |
| K220058 | 2022-06-01 | MSX | Traditional | This company |
| K220242 | 2022-03-25 | IYN | Traditional | This company |
| K220051 | 2022-03-04 | IYN | Traditional | This company |
| K212265 | 2021-11-16 | IYN | Traditional | This company |
| K212900 | 2021-11-05 | IYN | Traditional | This company |
| K211475 | 2021-10-05 | MWI | Traditional | This company |
| K211337 | 2021-07-01 | IYN | Traditional | This company |
| K210699 | 2021-06-10 | IYN | Traditional | This company |
| K210416 | 2021-06-10 | IYN | Traditional | This company |
| K201957 | 2021-03-26 | BSZ | Traditional | This company |
| K203391 | 2021-03-23 | IYN | Traditional | This company |
| K202405 | 2021-01-07 | MHX | Traditional | This company |
| K201990 | 2020-11-09 | IYN | Traditional | This company |
| K201693 | 2020-08-21 | IYN | Traditional | This company |
| K200643 | 2020-07-24 | IYN | Traditional | This company |
| K200015 | 2020-06-08 | MHX | Traditional | This company |
| K200979 | 2020-05-28 | IYN | Traditional | This company |
| K193391 | 2020-05-21 | MSX | Special | This company |
| K192972 | 2020-05-07 | MHX | Traditional | This company |
| K200001 | 2020-04-09 | IYN | Traditional | This company |
| K200411 | 2020-04-08 | IYN | Traditional | This company |
| K200251 | 2020-04-02 | IYN | Traditional | This company |
| K192410 | 2019-12-19 | IYN | Traditional | This company |
| K192152 | 2019-12-13 | IYN | Traditional | This company |
| K191769 | 2019-10-31 | MHX | Traditional | This company |
| K190011 | 2019-07-10 | MHX | Traditional | This company |
| K183660 | 2019-04-09 | IYN | Traditional | This company |
| K183377 | 2019-04-04 | IYN | Traditional | This company |
| K182821 | 2019-03-27 | MWI | Special | This company |
| K183238 | 2019-03-13 | MSX | Traditional | This company |
| K190206 | 2019-03-08 | IYN | Traditional | This company |
| K182636 | 2019-01-10 | IYN | Traditional | This company |
| K181637 | 2019-01-09 | IYN | Traditional | This company |
| K182075 | 2018-12-10 | MHX | Traditional | This company |
| K182603 | 2018-11-14 | IYN | Traditional | This company |
| K180788 | 2018-10-24 | BZK | Traditional | This company |
| K180912 | 2018-07-30 | IYN | Traditional | This company |
| K171311 | 2018-01-12 | BSZ | Traditional | This company |
| K171292 | 2018-01-12 | BSZ | Traditional | This company |
| K173471 | 2018-01-08 | IYN | Traditional | This company |
| K172860 | 2018-01-02 | IYN | Traditional | This company |
| K171901 | 2017-11-15 | MHX | Traditional | This company |
| K172970 | 2017-10-25 | IYN | Traditional | This company |
| K171579 | 2017-10-18 | IYN | Traditional | This company |
| K171891 | 2017-09-21 | IYN | Traditional | This company |
| K170876 | 2017-08-23 | MHX | Traditional | This company |
| K171034 | 2017-07-10 | IYN | Traditional | This company |
| K162607 | 2017-04-20 | MSX | Traditional | This company |
| K163690 | 2017-04-20 | IYN | Traditional | This company |
| K170277 | 2017-03-23 | IYN | Traditional | This company |
| K162845 | 2016-12-15 | IYN | Traditional | This company |
| K162267 | 2016-09-06 | IYN | Special | This company |
| K161525 | 2016-07-13 | IYN | Traditional | This company |
| K160370 | 2016-06-09 | JGS | Traditional | This company |
| K160381 | 2016-03-09 | IYN | Special | This company |
| K153448 | 2016-03-03 | MHX | Traditional | This company |
| K152902 | 2016-02-18 | MHX | Traditional | This company |
| K152543 | 2015-10-29 | IYN | Traditional | This company |
| K151954 | 2015-10-27 | BSZ | Traditional | This company |
| K152763 | 2015-10-21 | IYN | Traditional | This company |
| K152545 | 2015-10-02 | IYN | Traditional | This company |
| K150082 | 2015-09-02 | MHX | Traditional | This company |
| K150352 | 2015-09-02 | MHX | Traditional | This company |
| K150632 | 2015-07-06 | MSX | Traditional | This company |
| K150167 | 2015-06-30 | CAD | Traditional | This company |
| K150080 | 2015-06-12 | IYN | Special | This company |
| K150204 | 2015-04-10 | IYN | Traditional | This company |
| K142552 | 2015-01-23 | BSZ | Traditional | This company |
| K143472 | 2015-01-02 | IYN | Traditional | This company |
| K221267 | 2022-12-15 | MWI | Traditional | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. |
| K222754 | 2022-11-09 | IYN | Traditional | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. |
| K202785 | 2021-04-08 | IYN | Traditional | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. |
| K173369 | 2017-12-13 | IYN | Traditional | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. |
| K171233 | 2017-09-12 | IYN | Traditional | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. |
| K170712 | 2017-08-02 | MWI | Traditional | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. |
| K160606 | 2016-09-01 | JPK | Traditional | R & D Systems, Inc. |
| K160429 | 2016-09-01 | GKZ | Traditional | Mindray Bio-Medical Electronics Co., Ltd. |
| K143348 | 2015-08-21 | GKZ | Traditional | Mindray Bio-Medical Electronics Co., Ltd. |
| K151175 | 2015-05-15 | IYN | Special | Zonare Medical Systems, Inc. |
| K150249 | 2015-03-04 | IYN | Traditional | Zonare Medical Systems, Inc. |
| K143195 | 2014-12-22 | MHX | Traditional | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. |
| K132662 | 2014-08-01 | MHX | Special | Shenzhen Mindray Biomedical Electronics Co., Ltd. |
| K132037 | 2014-05-16 | MWI | Abbreviated | Mindray North America |
| K132038 | 2014-05-02 | MWI | Abbreviated | Mindray North America |
| K132026 | 2013-12-20 | MHX | Abbreviated | Mindray DS USA, Inc. |
| K123211 | 2013-02-14 | BSZ | Abbreviated | Datascope Corp., Patient Monitoring Division |
| K113632 | 2012-01-25 | IYO | Special | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. |
| K042276 | 2004-09-23 | CAD | Traditional | Draeger, Inc. |
| K971923 | 1997-09-16 | CAD | Traditional | Draeger, Inc. |
| K955925 | 1996-02-29 | KRX | Traditional | R & D Systems, Inc. |
| K843962 | 1984-11-01 | JPK | Traditional | R & D Systems, Inc. |
Showing 122 of 182.
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1991 |
|---|---|
| Employees | 21288 |
| Main products | Patient monitoring systems, Ultrasound equipment, Laboratory diagnostics, Anesthesia machines, Ventilators |
| Export markets | 150+ countries globally |
Nearby Manufacturers
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.