Guangdong Transtek Medical Electronics Co., Ltd.
Manufacturer and brand owner in Zhongshan, Guangdong, China. 11 device types, 36 products catalogued, 17 clearances.
Guangdong Transtek Medical Electronics Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Scale, Patient and 9 other device types. 36 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011420269 |
| FEI number | 3011420269 |
| DUNS | 679794078 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 广东乐心医疗电子股份有限公司 |
|---|---|
| Unified social credit code | 914420007408365594 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Zhongshan |
|---|---|
| Province | Guangdong |
| Address | Zone A, No.105, Dongli Road |
| Postal code | 528437 |
| Country | China |
What It Makes
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| TeleRPM | DXN | 8 |
| Meraw | DXN | 8 |
| Astart | DXN | 5 |
| Benecen | DXN | 5 |
| Lifehood | DXN | 5 |
| Renpho | DXN | 4 |
| Transtek | DXN | 3 |
| Brilliant Care | DXN | 2 |
| Douhao | DXN | 2 |
| TeleMate Health | DXN | 2 |
| Pulse | DXN | 2 |
| Caretouch | DXN | 2 |
| Coverich | DXN | 2 |
| CareSimple | DXN | 2 |
| Linner | QUG | 2 |
| Metene | DXN | 1 |
| Nuna | DXN | 1 |
| ethizo | DXN | 1 |
| WebCareHealth | DXN | 1 |
| Cadence | DXN | 1 |
| Insignia | DXN | 1 |
| Leraise | DXN | 1 |
| TeleRPM | PUH | 1 |
| Lifesense | DXN | 1 |
| DrKumo | DXN | 1 |
| Body Pixel | DXN | 1 |
| Corsano | DXN | 1 |
| Veris Health | DXN | 1 |
| TrueBlue MD | DXN | 1 |
| Health Wealth Safe | DXN | 1 |
| Patient Doctor Connect &TeleRPM | DXN | 1 |
| Health Connect | DXN | 1 |
| Ezfast | DXN | 1 |
| Riva Health | DXN | 1 |
| Pulse | PUH | 1 |
| RemoteCare 4U | DXN | 1 |
Clearances
17 clearances name Guangdong Transtek Medical Electronics Co., Ltd. as applicant. 10 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 |
|---|---|---|---|---|
| K243060 | 2025-01-30 | NBW | Traditional | This company |
| K241351 | 2024-08-21 | DXN | Special | This company |
| K240832 | 2024-06-07 | DXN | Traditional | This company |
| K240254 | 2024-05-31 | DXN | Traditional | This company |
| K240102 | 2024-04-29 | DXN | Traditional | This company |
| K233130 | 2023-12-20 | DXN | Traditional | This company |
| K232713 | 2023-11-28 | DXN | Traditional | This company |
| K232621 | 2023-11-22 | DXN | Traditional | This company |
| K223374 | 2023-06-30 | DXN | Traditional | This company |
| K220676 | 2022-08-29 | DXN | Traditional | This company |
| K202891 | 2021-03-09 | DXN | Traditional | This company |
| K202599 | 2020-12-06 | DXN | Traditional | This company |
| K181832 | 2019-04-09 | DXN | Traditional | This company |
| K161886 | 2016-10-14 | DXN | Special | This company |
| K131394 | 2013-09-18 | MNW | Special | This company |
| K131395 | 2013-06-19 | DXN | Special | This company |
| K130311 | 2013-05-30 | MNW | Traditional | This company |
| K243306 | 2024-11-15 | QRL | Special | Tianjin Huahong Technology Co., Ltd. |
| K223722 | 2023-06-28 | NBW | Traditional | MIO Labs Inc. |
| K220475 | 2022-07-06 | QRL | Traditional | Tianjin Huahong Technology Co., Ltd. |
| K191430 | 2019-10-18 | DQA | Traditional | Shenzhen Yimi Life Technology Co., Ltd. |
| K173140 | 2018-12-19 | NBW | Traditional | Vivachek Laboratories, Inc. |
| K172141 | 2018-04-04 | DQA | Traditional | Shanghai Berry Electronic Tech Co., Ltd. |
| K123780 | 2013-03-01 | DXN | Special | Zhongshan Transtek Electronics Co., Ltd. |
| K123669 | 2012-12-21 | DXN | Special | Zhongshan Transtek Electronics Co., Ltd. |
| K122482 | 2012-10-22 | DXN | Abbreviated | Zhongshan Transtek Electronics Co., Ltd. |
| K120058 | 2012-01-31 | DXN | Special | Zhongshan Transtek Electronics Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Employees | 1089 |
| Main products | Blood pressure monitors, Glucose monitors, Weight scales, Pulse oximeters, Gateway devices |
| Certifications | ISO 9001:2022, ISO 13485:2022, ISO 14001:2022, ISO 45001:2023, QC080000:2023, FDA, TGA |
| Export markets | Worldwide, APAC, US |
| OEM and ODM | Offered |
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.