micsafe 1
by Jiangsu Micsafe Medical Tehcnology Co., LTD. 24 variants
micsafe 1 is a Class II device made by Jiangsu Micsafe Medical Tehcnology Co., LTD., cleared under FDA 510(k) K212019 on 4 Nov 2021 and listed in FDA GUDID since 31 May 2023 (UDI-DI 06971911291556), 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 | Number06971911291556 | Date31 May 2023 | StatusListed |
| United States | FDA 510(k) | NumberK212019 | Date4 Nov 2021 | StatusActive |
Official records
- AccessGUDID record 06971911291556
- FDA 510(k) database K212019
Across registries
- FDA 510(k) K212019 decided 4 Nov 2021 Active
- FDA GUDID UDI-DI 06971911291556 listed 31 May 2023 Listed
Timeline
- Cleared FDA 510(k) K212019
- Listed FDA GUDID 06971911291556
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- micsafe
- Generic name
- Blood collection tube holder/needle
- Model / reference
- 1
- Primary DI / UDI-DI
- 06971911291556
- 510(k) Number
- FDA product code
- JKA
- GMDN term
- Blood collection tube holder/needle
- Device class
- Class II
- Regulation number
- 862.1675
- GUDID distribution status
- In Commercial Distribution
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