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PIVKA-II Detection Kit (Chemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 3010686Model 1×100 Tests/kitRef 3010666Model 1×50 Tests/kitRef 3014256Model 2×50 Tests/kit

by Dirui Industrial Co., Ltd

Identity

Trade Name
PIVKA-II Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Device Name
PIVKA-II Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Model / Reference
1×100 Tests/kit EUDAMED
3010686 EUDAMED
1×50 Tests/kit EUDAMED
3010666 EUDAMED
2×50 Tests/kit EUDAMED
3014256 EUDAMED

Identifiers

Primary DI / UDI-DI
06925794571434 EUDAMED
06925794571427 EUDAMED
06942202224317 EUDAMED
Basic UDI-DI
B-06925794571434 EUDAMED
B-06925794571427 EUDAMED
B-06942202224317 EUDAMED
EMDN Code
W0102030199 CANCER ANTIGENS - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria 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

PIVKA-II Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Dirui Industrial Co., Ltd
EUDAMED SRN
CN-MF-000001891
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED 45c31985-f26f-4e6d-b253-fbc75342a419 61 fields · synced Jul 26, 2026
  • EUDAMED b69f9980-3d6e-4f94-87bc-9ec644203e98 61 fields · synced May 17, 2026
  • EUDAMED 56503cf8-54c5-431a-a76c-d4de35048850 61 fields · synced May 17, 2026