Identity
- Trade Name
- HOKAPI™ ANTI-TPO EUDAMED
- Device Name
- HOKAPI™ ANTI-TPO EUDAMED
- Model / Reference
- 010305101 EUDAMED010309601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971390434888 EUDAMED06939716404885 EUDAMED
- Basic UDI-DI
- 697139043030983 EUDAMED
- Direct Marketing DI
- 06971390434888 EUDAMED06939716404885 EUDAMED
- EMDN Code
- W0102100301 THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES 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™ Anti-Tpo 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 | 697139043030983 | 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 (2)
- EUDAMED f3d7b083-9908-40a3-9332-d23298def099 61 fields · synced Jul 9, 2026
- EUDAMED 14e109b6-7756-4c36-8c7f-e79915581b49 61 fields · synced May 17, 2026