AlphaMed UFR105
by Shenzhen Urion Technology Co., Ltd
AlphaMed UFR105 is a Class II device made by Shenzhen Urion Technology Co., Ltd, cleared under FDA 510(k) K200802 on 7 Oct 2020 and listed in FDA GUDID since 19 Oct 2020 (UDI-DI 06953825904029), 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 | Number06953825904029 | Date19 Oct 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200802 | Date7 Oct 2020 | StatusActive |
Official records
- AccessGUDID record 06953825904029
- FDA 510(k) database K200802
Across registries
- FDA 510(k) K200802 decided 7 Oct 2020 Active
- FDA GUDID UDI-DI 06953825904029 listed 19 Oct 2020 Listed
Timeline
- Cleared FDA 510(k) K200802
- Listed FDA GUDID 06953825904029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AlphaMed
- Generic name
- Infrared patient thermometer, ear/skin
- Model / reference
- UFR105
- Primary DI / UDI-DI
- 06953825904029
- 510(k) Number
- FDA product code
- FLL
- GMDN term
- Infrared patient thermometer, ear/skin
- Device class
- Class II
- Regulation number
- 880.2910
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Infrared patient thermometer, ear/skin.