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Hokapi™ Nt-Probnp
EUDAMEDClass C (EU MDR)
Ref 010706001Ref 010706601Ref 010706101
Identity
- Trade Name
- HOKAPI™ NT-PROBNP EUDAMED
- Device Name
- HOKAPI™ NT-PROBNP EUDAMED
- Model / Reference
- 010706001 EUDAMED010706601 EUDAMED010706101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716405196 EUDAMED06939716405202 EUDAMED06971390439937 EUDAMED
- Basic UDI-DI
- 69713904307068H EUDAMED
- Direct Marketing DI
- 06939716405196 EUDAMED06939716405202 EUDAMED06971390439937 EUDAMED
- EMDN Code
- W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED
Classification
- Device Class
- Class C 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™ Nt-Probnp by Suzhou Hokapi Biomedical Engineering Co., Ltd.. — Class C — 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 | 69713904307068H | Class C | 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 (3)
- EUDAMED 934adf82-7132-4fce-851a-28ed65de5535 61 fields · synced Jul 22, 2026
- EUDAMED c1973686-de9d-4dd3-8a3a-117211083aab 61 fields · synced May 18, 2026
- EUDAMED c28845fd-7c06-4a41-bb62-7690248e830e 61 fields · synced May 18, 2026