Data / Medical devices / China / Hangzhou Universal Electronic Co., Ltd.
Hangzhou Universal Electronic Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 2 510(k) clearances
Hangzhou Universal Electronic Co., Ltd. is registered with the FDA (registration 3008754120) in Hangzhou Zhejiang, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 24, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008754120
- Address
- 298 Yunxi Road, Cangqian Street, Yuhang District, Hangzhou Zhejiang, China, 311121
- Owner or operator
- Hangzhou Universal Electronic Co., Ltd. (10034707)
- Roles
- Manufacturer
- First device listed
- December 23, 2010
- Registered through
- 2026
- Brand names listed
- Clinical electronic thermometer, Clinical thermometer, Digital Thermometer, Multiple Models, Digital thermometer, FT-100A, FT-100B, FT-100C, GF-MT101, GF-MT102, GF-MT103, GF-MT104, GF-MT105, GF-MT106, GF-MT107, GF-MT108, GF-MT109 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 24, 2016 | K160802 | Infrared Forehead Thermometer, FT-100A | FLL | Substantially Equivalent | Hangzhou Universal Electronic Co., Ltd. | accessdata.fda.gov |
| December 13, 2010 | K102718 | DIGITAL THERMOMETER; DIGITAL THERMOMETER | FLL | Substantially Equivalent | International Regulatory Consultants, LLC (Irc) | accessdata.fda.gov |
Compare with other makers
Updated August 24, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.