Asa As-Mc-Sr-Kit
by Wenzhou Caretek Medical Device Co., Ltd.
Asa As-Mc-Sr-Kit is a Class II device made by Wenzhou Caretek Medical Device Co., Ltd., cleared under FDA 510(k) K230859 on 28 Jun 2023 and listed in FDA GUDID since 14 May 2024 (UDI-DI 06975871430390), active as of 23 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 | Number06975871430390 | Date14 May 2024 | StatusListed |
| United States | FDA 510(k) | NumberK230859 | Date28 Jun 2023 | StatusActive |
Official records
- AccessGUDID record 06975871430390
- FDA 510(k) database K230859
Across registries
- FDA 510(k) K230859 decided 28 Jun 2023 Active
- FDA GUDID UDI-DI 06975871430390 listed 14 May 2024 Listed
Timeline
- Cleared FDA 510(k) K230859
- Listed FDA GUDID 06975871430390
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Asa
- Generic name
- Aneroid manual sphygmomanometer
- Model / reference
- AS-MC-SR-KIT
- Primary DI / UDI-DI
- 06975871430390
- 510(k) Number
- FDA product code
- DXQ
- GMDN term
- Aneroid manual sphygmomanometer
- Device class
- Class II
- Regulation number
- 870.1120
- GUDID distribution status
- In Commercial Distribution
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