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Cancer Antigen 125 Detection Kit (Chemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 3013894Model 2×50 tests/kitRef 3013704Model 1×50 tests/kitRef 3008802Model 1×100 tests/kit

by Dirui Industrial Co., Ltd

Identity

Trade Name
Cancer Antigen 125 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Device Name
Cancer Antigen 125 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Model / Reference
2×50 tests/kit EUDAMED
3013894 EUDAMED
1×50 tests/kit EUDAMED
3013704 EUDAMED
1×100 tests/kit EUDAMED
3008802 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202224225 EUDAMED
06925794520838 EUDAMED
06925794514424 EUDAMED
Basic UDI-DI
B-06942202224225 EUDAMED
B-06925794520838 EUDAMED
B-06925794514424 EUDAMED
EMDN Code
W0102030106 CANCER ANTIGEN 125 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

Cancer Antigen 125 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 7566c20b-b3b1-4377-97bf-b94f8b51c6c0 61 fields · synced Sep 30, 2026
  • EUDAMED 71912cf5-6853-4a5d-9bdb-c07bfbba6c4c 61 fields · synced May 17, 2026
  • EUDAMED 09160eaa-561b-467f-9006-c3284084343b 61 fields · synced May 17, 2026