Manufacturer and brand owner in Zhongshan, Guangdong, China. 5 device types, 17 products catalogued, 9 clearances.
Zhongshan Transtek Electronics Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Scale, Patient, Scale, Stand-On, Patient and 3 other device types. 17 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2012.
Registration
FDA registration record for Zhongshan Transtek Electronics Co., Ltd. | Registered name | Zhongshan Transtek Electronics Co., Ltd |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008485370 |
| FEI number | 3008485370 |
| DUNS | 544411562 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
Address of Zhongshan Transtek Electronics Co., Ltd. | City | Zhongshan |
| Province | Guangdong |
| Address | Zone E, No. 105, Dongli Road |
| Postal code | 528437 |
| Country | China |
Clearances
9 clearances name Zhongshan Transtek Electronics 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.
From the Company
Published by the company on its own website, not by the FDA.
Information published by Zhongshan Transtek Electronics Co., Ltd. | Founded | 2000 |
| Factory area | 70,000 ㎡ |
| Main products | Electronic scales, Blood pressure monitors, Blood glucose monitors, Wearables, ECG devices |
| Certifications | ISO9001, ISO45001, ISO14001, ISO13485, BSCI, FSC, CSR |
| Export markets | 90+ countries and regions |
| OEM and ODM | Offered |
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.