Identity
- Device Name
- AIA-PACK PIVKA-II CONTROL SET EUDAMED
- Model / Reference
- 0025433 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560189213111 EUDAMED
- Basic UDI-DI
- B-04560189213111 EUDAMED
- EMDN Code
- W0102039017 PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Aia-Pack Pivka-Ii Control Set by Tosoh Corporation — 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-04560189213111 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (1)
- EUDAMED 38d5faad-12f0-4010-ab4a-6fb698e7723d 61 fields · synced Jun 18, 2026