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Cancer Antigen 242 Detection Kit (Chemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 3010701Model 1×100 Tests/kit

by Dirui Industrial Co., Ltd

Identity

Trade Name
Cancer Antigen 242 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Device Name
Cancer Antigen 242 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Model / Reference
1×100 Tests/kit EUDAMED
3010701 EUDAMED

Identifiers

Primary DI / UDI-DI
06925794521033 EUDAMED
Basic UDI-DI
B-06925794521033 EUDAMED
EMDN Code
W0102030108 CANCER ANTIGEN 242 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 242 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

EUDAMED SRN
CN-MF-000001891
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (1)

  • EUDAMED dbd2b06f-67fb-4c8a-9e16-eee6b6f4cefc 61 fields · synced Jul 23, 2026