sunmark HCG-M01
by Nantong Egens Biology Technic Co., Ltd.
sunmark HCG-M01 is a Class II device made by Nantong Egens Biology Technic Co., Ltd., cleared under FDA 510(k) K123050 on 5 Feb 2013 and listed in FDA GUDID since 14 Nov 2022 (UDI-DI 06937579913735), 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 | Number06937579913735 | Date14 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123050 | Date5 Feb 2013 | StatusActive |
Official records
- AccessGUDID record 06937579913735
- FDA 510(k) database K123050
Across registries
- FDA 510(k) K123050 decided 5 Feb 2013 Active
- FDA GUDID UDI-DI 06937579913735 listed 14 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K123050
- Listed FDA GUDID 06937579913735
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- sunmark
- Generic name
- Human chorionic gonadotropin alpha-subunit IVD, calibrator
- Model / reference
- HCG-M01
- Primary DI / UDI-DI
- 06937579913735
- 510(k) Number
- FDA product code
- LCX
- GMDN term
- Human chorionic gonadotropin alpha-subunit IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1155
- GUDID distribution status
- In Commercial Distribution
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