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Protein Induced by Vitamin K Absence or Antagonist-II Chemiluminescence Immunoa…
EUDAMEDClass IVD General (EU MDR)
Ref S2147E-50Ref S2147E-200Ref S2147E-100Ref S2147E-75
Identity
- Device Name
- Protein Induced by Vitamin K Absence or Antagonist-II Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2147E-50 EUDAMEDS2147E-200 EUDAMEDS2147E-100 EUDAMEDS2147E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792742635 EUDAMED06955792742673 EUDAMED06955792742659 EUDAMED06955792742642 EUDAMED
- Basic UDI-DI
- B-06955792742635 EUDAMEDB-06955792742673 EUDAMEDB-06955792742659 EUDAMEDB-06955792742642 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
- France 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
Protein Induced by Vitamin K Absence or Antagonist-II Chemiluminescence Immunoa… by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED
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-06955792742635 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED 4696ede1-d134-4654-b42e-45799065b482 61 fields · synced Oct 6, 2026
- EUDAMED 3c97a2c2-f0d3-4aec-b8dd-fcc52ecc17e5 61 fields · synced May 17, 2026
- EUDAMED 2424db76-55ad-44aa-8205-c5fa68700e42 61 fields · synced May 18, 2026
- EUDAMED a0a4d1ac-057c-4e00-b12d-cdd8ee190949 61 fields · synced May 18, 2026