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Hokapi™ Ft4
EUDAMEDClass B (EU MDR)
Ref 010302101Ref 010302601Ref 010302001Ref 010302401
Identity
- Trade Name
- HOKAPI™ FT4 EUDAMED
- Device Name
- HOKAPI™ FT4 EUDAMED
- Model / Reference
- 010302101 EUDAMED010302601 EUDAMED010302001 EUDAMED010302401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971390434840 EUDAMED06939716404762 EUDAMED06939716404755 EUDAMED06971390434833 EUDAMED
- Basic UDI-DI
- 69713904303027M EUDAMED
- Direct Marketing DI
- 06971390434840 EUDAMED06939716404762 EUDAMED06939716404755 EUDAMED06971390434833 EUDAMED
- EMDN Code
- W01020402 FREE THYROXINE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Hokapi™ Ft4 by Suzhou Hokapi Biomedical Engineering Co., Ltd.. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69713904303027M | Class B | Active |
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Manufacturer
- Manufacturer
- Suzhou Hokapi Biomedical Engineering Co., Ltd..
- EUDAMED SRN
- CN-MF-000013723
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED d79901e7-514c-410e-9c2d-34fb94868fc5 61 fields · synced Aug 1, 2026
- EUDAMED a9ae20a8-bed5-4765-a627-37c781c245b4 61 fields · synced May 18, 2026
- EUDAMED 1fb96038-1471-4d39-8d94-0010f7c30bac 61 fields · synced May 18, 2026
- EUDAMED ef59a215-69e1-4700-a7c1-5ecb7c73fbc1 61 fields · synced May 18, 2026