Hokapi™ T4
by Suzhou Hokapi Biomedical Engineering Co., Ltd.. 3 variants
Ref 010305601
Hokapi T4 (010305601) is an in vitro diagnostic device (EU IVDR Class B; EMDN category thyroxine) made by Suzhou Hokapi Biomedical Engineering Co., Ltd.., registered in EUDAMED on 26 Mar 2026 (Basic UDI-DI 69713904303057T), 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 | Number69713904303057T 06939716404823 | Date26 Mar 2026 | StatusActive |
Official records
- EUDAMED public site 69713904303057T
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / reference
- 010305601
- Primary DI / UDI-DI
- 06939716404823
- Basic UDI-DI
- 69713904303057T
- Direct marketing DI
- 06939716404823
- EMDN code
- W01020407 Thyroxine
- Device class
- Class B
- 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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