Hokapi™ Ca 72-4
by Suzhou Hokapi Biomedical Engineering Co., Ltd.. 3 variants
Ref 010111001
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69713904301117C 06939716404571 | Date10 Dec 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Hokapi™ CA72-4
- Model / Reference
- 010111001
- Primary DI / UDI-DI
- 06939716404571
- Basic UDI-DI
- 69713904301117C
- Direct Marketing DI
- 06939716404571
- EMDN Code
- W0102030105 Cancer antigen 72-4
- Device Class
- Class C
- 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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Properties
Other properties (7)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No