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PIVKA-Ⅱ CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB2003Model AutoLumo analyzerRef CMB2007Ref CMB2005
Identity
- Trade Name
- PIVKA-Ⅱ CLIA Microparticles EUDAMEDPIVKA-II CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB2003 EUDAMEDCMB2007 EUDAMEDCMB2005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359549691 EUDAMED06942359517218 EUDAMED06942359549714 EUDAMED
- Basic UDI-DI
- 697015090000083HE EUDAMED
- EMDN Code
- W0102039017 PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMEDEUDAMED
PIVKA-Ⅱ CLIA Microparticles by Autobio Diagnostics 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 | 697015090000083HE | Class C | Active |
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Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED e9aba15c-361e-4d73-ac08-d11ed2850133 61 fields · synced Jul 19, 2026
- EUDAMED d985bfb9-8bf9-4a02-ac60-87df9e717dcd 61 fields · synced May 17, 2026
- EUDAMED 56c44708-1784-4b42-b3f3-4c50c4c07742 61 fields · synced May 18, 2026