Protein Induced by Vitamin K Absence or Antagonist-II Assay Kit (Chemiluminesce…

EUDAMED

Class IVD General (EU MDR)

Ref S2120E-48Ref S2120E-24Ref 50 testsModel 25 tests，50 tests，2×50 tests，100 tests，2×100 testsRef 25 tests

by Sansure Biotech Inc.

Identity

Trade Name: Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method） EUDAMED
Device Name: Protein Induced by Vitamin K Absence or Antagonist-II Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method） EUDAMED
Model / Reference: S2120E-48 EUDAMED
S2120E-24 EUDAMED
25 tests，50 tests，2×50 tests，100 tests，2×100 tests EUDAMED
50 tests EUDAMED
25 tests EUDAMED

Identifiers

Primary DI / UDI-DI: 06955792741317 EUDAMED
06955792741300 EUDAMED
06978465236460 EUDAMED
06978465236453 EUDAMED
Basic UDI-DI: B-06955792741317 EUDAMED
B-06955792741300 EUDAMED
697846523TumorC029X EUDAMED
EMDN Code: W0102039017 PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II) EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Class C EUDAMED
Market of Registration: France EUDAMED
Austria EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMEDEUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Protein Induced by Vitamin K Absence or Antagonist-II Assay Kit (Chemiluminesce… by Sansure Biotech Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	B-06955792741317	Class IVD General	Active
EUDAMED	European Union	CE/IVDD	B-06955792741317	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 3c084f1e-919c-4998-aa3d-b80f9ab03957 61 fields · synced Oct 6, 2026
EUDAMED 8c8a4280-2f2a-4a1d-bc05-43f8f59e9d41 61 fields · synced May 18, 2026
EUDAMED 11d81a3e-e6c0-4eb1-b68a-5bfa5209131d 61 fields · synced Jul 19, 2026
EUDAMED a3fc58a2-8e96-480e-9b06-20d92266282a 61 fields · synced Jul 30, 2026