Alphagomed U87E
by Shenzhen Urion Technology Co., Ltd
Alphagomed U87E (Yes) 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 Feb 2023 (UDI-DI 06953825906733), 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 | Number06953825906733 | Date13 Feb 2023 | StatusListed |
Official records
- AccessGUDID record 06953825906733
- FDA 510(k) database K243115
Across registries
- FDA 510(k) K243115 decided 21 Feb 2025 Active
- FDA GUDID UDI-DI 06953825906733 listed 13 Feb 2023 Listed
Timeline
- Listed FDA GUDID 06953825906733
- Cleared FDA 510(k) K243115
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Alphagomed
- Generic name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
- Model / Ref / Catalog
- U87E, Yes
- Primary DI / UDI-DI
- 06953825906733
- 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
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