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HOKAPI™ SARS-CoV-2 IgM
EUDAMEDClass IVD General (EU MDR)
Ref 010220101Model 100 TESTS
Identity
- Trade Name
- HOKAPI™ SARS-CoV-2 IgM EUDAMED
- Device Name
- HOKAPI™ SARS-CoV-2 IgM EUDAMED
- Model / Reference
- 100 TESTS EUDAMED010220101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971390439999 EUDAMED
- Basic UDI-DI
- B-06971390439999 EUDAMED
- EMDN Code
- W0105040619 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
HOKAPI™ SARS-CoV-2 IgM by Suzhou Hokapi Biomedical Engineering Co., Ltd.. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971390439999 | Class IVD General | 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 (1)
- EUDAMED 5dc9d9bb-32a2-4181-9b64-4ae16d3a922b 61 fields · synced Jun 18, 2026