Hangzhou Universal Electronic Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 2 device types, 5 products catalogued, 1 clearance.
Hangzhou Universal Electronic Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Clinical Electronic Thermometer, Continuous Measurement Thermometer. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
Registration
| Registered name | HANGZHOU UNIVERSAL ELECTRONIC CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008754120 |
| FEI number | 3008754120 |
| DUNS | 679945639 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 杭州广发电子技术有限公司 |
|---|---|
| Unified social credit code | 91330106790902649R |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | 298 Yunxi Road, Cangqian Street, Yuhang District |
| Postal code | 311121 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clinical Electronic Thermometer | Class 2 | Infrared thermometer, Infrared ear thermometer, ET-100A, ET-100B, ET-100C, ET-100D, ET-100E, Clinical thermometer, Infrared forehead thermometer, FT-100A, FT-100B, FT-100C, FT-100D, FT-100E, FT-100F, Infrared ear/forehead thermometer, EF-100A, EF-100B, EF-100C, EF-100D, EF-100E, EF-100F, EF-100G, EF-100H, Clinical electronic thermometer and 1 more | 2025 | 49 |
| Continuous Measurement Thermometer | Class 2 | Digital Thermometer, Multiple Models, VDTS-100U,EDTS-100U,VDTS-100R,VDTS-100B, Renewed Energy, Digital Thermometer, 121811/11012340, GF-MT501, GF-MT502, GF-MT503, GF-MT504, GF-MT505, GF-MT506, GF-MT507, GF-MT508, GF-MT509, GF-MT801, GF-MT802, GF-MT803, GF-MT101, GF-MT102, GF-MT103, GF-MT104, GF-MT105, GF-MT106, GF-MT107, GF-MT108, GF-MT109 and 5 more | 2010 | 115 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| NTI | FLL | 6 |
| Boncare | FLL | 3 |
| Familycare | FLL | 1 |
| Continuous Measurement Thermometer | FLL | 1 |
Clearances
1 clearance names Hangzhou Universal Electronic 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 |
|---|---|---|---|---|
| K160802 | 2016-08-24 | FLL | Traditional | This company |
| K102718 | 2010-12-13 | FLL | Traditional | International Regulatory Consultants, LLC (Irc) |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Employees | 125 |
| Factory area | 18633 m² |
| Main products | digital thermometer, infrared thermometer, blood pressure monitor, nebulizer, nose aspirator |
| Certifications | CE, FDA, ISO 13485, ISO, ROHS |
| Export markets | 40 countries |
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.