Hokapi™ D-Dimer
by Suzhou Hokapi Biomedical Engineering Co., Ltd.. 2 variants
Ref 010714601, 010714001, 010714401
Hokapi D-Dimer (010714601) is an in vitro diagnostic device (EU IVDR Class C; EMDN category D-dimer) made by Suzhou Hokapi Biomedical Engineering Co., Ltd.., registered in EUDAMED on 27 Mar 2026 (Basic UDI-DI 693971640714M5), active as of 24 Oct 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number693971640714M5 | Date27 Mar 2026 | StatusActive |
Official records
- EUDAMED public site 693971640714M5
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / reference
- 010714601, 010714001, 010714401
- Primary DI / UDI-DI
- 06939716405240, 06939716405233, 06939716400160
- Basic UDI-DI
- 693971640714M5
- Direct marketing DI
- 069397164052400693971640523306939716400160
- EMDN code
- W0103020503 D-dimer
- Device class
- Class C
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000013723
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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