Alphamed U82E
by Shenzhen Urion Technology Co., Ltd
Alphamed U82E is a Class II device made by Shenzhen Urion Technology Co., Ltd, cleared under FDA 510(k) K243115 on 21 Feb 2025 and listed in FDA GUDID since 13 Dec 2021 (UDI-DI 06953825905521), 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 | FDA 510(k)SESE | NumberK243115 | Date21 Feb 2025 | StatusActive |
| United States | GUDID listing | Number06953825905521 | Date13 Dec 2021 | StatusListed |
Official records
- AccessGUDID record 06953825905521
- FDA 510(k) database K243115
Across registries
- FDA 510(k) K243115 decided 21 Feb 2025 Active
- FDA GUDID UDI-DI 06953825905521 listed 13 Dec 2021 Listed
Timeline
- Listed FDA GUDID 06953825905521
- Cleared FDA 510(k) K243115
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Alphamed
- Generic name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
- Model / reference
- U82E
- Primary DI / UDI-DI
- 06953825905521
- 510(k) Number
- FDA product code
- DXN
- GMDN term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
- Device class
- Class II
- Regulation number
- 870.1130
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Automatic-inflation electronic sphygmomanometer, portable, arm/wrist.