FDA Registration
Active
🇨🇳 China
Digital Thermometer, Multiple Models
Reg #: 3008754120
·
FEI: 3008754120
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HANGZHOU UNIVERSAL ELECTRONIC CO., LTD.
- Registration Number
- 3008754120
- FEI Number
- 3008754120
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 298 Yunxi Road, Cangqian Street, Yuhang District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K102718
Owner / Operator
- Firm Name
- Hangzhou Universal Electronic Co., Ltd.
- Operator Number
- 10034707
- Address
- 298 Yunxi Road, Cangqian Street, Yuhang District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311121
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2010-12-23 |
Proprietary Names
Digital Thermometer, Multiple Models
VDTS-100U,EDTS-100U,VDTS-100R,VDTS-100B
Renewed Energy, Digital Thermometer, 121811/11012340
GF-MT101, GF-MT102, GF-MT103, GF-MT104, GF-MT105, GF-MT106, GF-MT107, GF-MT108, GF-MT109
GF-MT501, GF-MT502, GF-MT503, GF-MT504, GF-MT505, GF-MT506, GF-MT507, GF-MT508, GF-MT509
GF-MT801, GF-MT802, GF-MT803
Establishment Types
Manufacture Medical Device