Guangdong Biolight Meditech Co., Ltd.
Manufacturer and brand owner in Zhuhai, Guangdong, China. 19 device types, 14 products catalogued, 21 clearances.
Guangdong Biolight Meditech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Electrocardiograph and 17 other device types. 14 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
19device types registered with the FDA
14products catalogued under its own name
21510(k) clearances
Registration
| Registered name | GUANGDONG BIOLIGHT MEDITECH CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007305624 |
| FEI number | 3007305624 |
| DUNS | 530120146 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 广东宝莱特医用科技股份有限公司 |
|---|---|
| Unified social credit code | 914404006175020946 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Zhuhai |
|---|---|
| Province | Guangdong |
| Address | No.9 Yonghe Road |
| Postal code | 519085 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor, TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor, M69, M7000, M8000, M9000 Patient Monitor, M8000A, M9000A Patient Monitor | 2010 | 29 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor | 2013 | 6 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Class 2 | Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor | 2013 | 6 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | Class 2 | Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor | 2013 | 6 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | Class 2 | Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor | 2013 | 8 |
| Computer, Blood-Pressure | Class 2 | Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor, TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor, M69, M7000, M8000, M9000 Patient Monitor, M8000A, M9000A Patient Monitor | 2010 | 12 |
| Continuous Measurement Thermometer | Class 2 | Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor | 2013 | 115 |
| Detector And Alarm, Arrhythmia | Class 2 | Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor | 2013 | 10 |
| Dislodger, Stone, Basket, Ureteral, Metal | Class 2 | TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor, M69, M7000, M8000, M9000 Patient Monitor, M8000A, M9000A Patient Monitor | 2010 | 21 |
| Electrocardiograph | Class 2 | E70 Digital Electrocardiograph, E80 Digital Electrocardiograph, E30 Digital Electrocardiograph | 2015 | 18 |
| Monitor, Breathing Frequency | Class 2 | TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor, M69, M7000, M8000, M9000 Patient Monitor, M8000A, M9000A Patient Monitor | 2010 | 8 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Class 2 | Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor, M800 Handheld Monitor, TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor, M69, M7000, M8000, M9000 Patient Monitor, M8000A, M9000A Patient Monitor and 3 more | 2010 | 9 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class 2 | Vital Signs Monitor SignaPulse 100, Vital Signs Monitor V6, Vital Signs Monitor VS1, Vital Signs Monitor PMVSM5000, M800 Handheld Monitor, AnyView A8, AnyView A6, AnyView A5, AnyView A3 patient monitor and 3 more | 2012 | 17 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Class 2 | Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor, M8000/M9000/M8000A/M9000A patient monitor, Patient Monitor M8500, TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor, M69, M7000, M8000, M9000 Patient Monitor and 4 more | 2010 | 9 |
| Monitor, St Segment With Alarm | Class 2 | Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor | 2013 | 7 |
| Oximeter | Class 2 | M800, ARGUS OXM plus Handheld Pulse Oximeter, Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor, M800 Handheld Monitor, Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D, Fingertip Pulse Oximeters M70A, M70B,M70C and 5 more | 2008 | 70 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | M50, M50A, M50L oximeter, GPD-PO1GR01C | 2019 | 29 |
| Plethysmograph, Impedance | Class 2 | Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor | 2013 | 5 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor, Truscope Classic,Truscope II,Truscope MINI patient monitor, WBP100,WBP201,WBP202 Electronic Sphygmomanometer, TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor, M69, M7000, M8000, M9000 Patient Monitor, M8000A, M9000A Patient Monitor and 3 more | 2010 | 98 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Patient Monitor | MWI | 8 |
| Patient Monitor | MHX | 7 |
| Fetal monitor | HGM | 4 |
| Fingertip Pluse Oximeter | DQA | 4 |
| Fingertip Pulse Oximeter | OCH | 3 |
| Electronic thermoneter | FLL | 2 |
| Digital Electrocardigraph | DPS | 2 |
| Fingertip Pluse Oximter | DQA | 1 |
| handheld monitor | HGM | 1 |
| Handheld Pulse Oximeter | DQA | 1 |
| Electronic Sphygmomanometer | DXN | 1 |
| Vital Signs Monitor | MWI | 1 |
| Handheld Pulse Monitor | DQA | 1 |
| Digital Electrocardiograph | DPS | 1 |
Clearances
21 clearances name Guangdong Biolight Meditech Co., Ltd. as applicant. 1 is held by another company 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 |
|---|---|---|---|---|
| K181919 | 2019-04-05 | MWI | Traditional | This company |
| K170514 | 2017-05-24 | MHX | Traditional | This company |
| K162234 | 2017-01-04 | MWI | Special | This company |
| K160349 | 2016-11-03 | DXN | Traditional | This company |
| K153580 | 2016-09-07 | HGM | Traditional | This company |
| K153135 | 2016-02-25 | MWI | Special | This company |
| K152739 | 2016-02-09 | FLL | Traditional | This company |
| K151287 | 2016-01-06 | DQA | Traditional | This company |
| K131858 | 2014-06-11 | DPS | Traditional | This company |
| K131762 | 2014-06-06 | MWI | Traditional | This company |
| K131941 | 2014-05-15 | HGM | Traditional | This company |
| K131898 | 2014-02-18 | MWI | Traditional | This company |
| K131763 | 2013-07-15 | MHX | Special | This company |
| K120193 | 2012-06-29 | MWI | Traditional | This company |
| K113833 | 2012-05-01 | MWI | Traditional | This company |
| K112804 | 2012-01-27 | DQA | Special | This company |
| K112803 | 2011-10-24 | MHX | Special | This company |
| K102040 | 2010-09-24 | MHX | Special | This company |
| K101694 | 2010-09-08 | DQA | Special | This company |
| K100046 | 2010-04-08 | MHX | Traditional | This company |
| K081712 | 2008-09-12 | DQA | Traditional | This company |
| K131876 | 2014-02-27 | MHX | Special | Mid-Link Consulting Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1993 |
|---|---|
| Main products | Monitoring devices, Dialysis equipment, Home medical devices, Blood purification systems |
| Certifications | National High-Tech Enterprise, National Multi-parameter Monitor Industrialization Base |
| Export markets | 80+ countries including India and Africa |
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.
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