Alphamed Het-R171
by Shenzhen Urion Technology Co., Ltd
Alphamed Het-R171 is a Class II device made by Shenzhen Urion Technology Co., Ltd, cleared under FDA 510(k) K172891 and listed in FDA GUDID since 10 Apr 2020 (UDI-DI 06953825909031), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06953825909031 | Date10 Apr 2020 | StatusListed |
| United States | FDA 510(k) | NumberK172891 | Date— | StatusActive |
Official records
- AccessGUDID record 06953825909031
- FDA 510(k) database K172891
Across registries
- FDA 510(k) K172891 Active
- FDA GUDID UDI-DI 06953825909031 listed 10 Apr 2020 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Alphamed
- Generic name
- Infrared patient thermometer, skin
- Model / reference
- HET-R171
- Primary DI / UDI-DI
- 06953825909031
- 510(k) Number
- FDA product code
- FLL
- GMDN term
- Infrared patient thermometer, skin
- Device class
- Class II
- Regulation number
- 880.2910
- GUDID distribution status
- In Commercial Distribution
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