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PIVKA-II Chemiluminescent Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref IM4494129
Identity
- Device Name
- PIVKA-II Chemiluminescent Immunoassay Kit EUDAMED
- Model / Reference
- IM4494129 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-IM4494129MC EUDAMED
- Basic UDI-DI
- B-IM4494129MC EUDAMED
- EMDN Code
- W0102030199 CANCER ANTIGENS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
PIVKA-II Chemiluminescent Immunoassay Kit by Maccura Biotechnology 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-IM4494129MC | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED a4bce14e-5666-439c-b605-27ca206ec746 61 fields · synced Jun 19, 2026