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CA 242 Chemiluminescent Immunoassay Kit

EUDAMED

Class IVD General (EU MDR)

Ref IM4407114

by Maccura Biotechnology Co., Ltd.

Identity

Device Name
CA 242 Chemiluminescent Immunoassay Kit EUDAMED
Model / Reference
IM4407114 EUDAMED

Identifiers

Primary DI / UDI-DI
D-IM4407114JH EUDAMED
Basic UDI-DI
B-IM4407114JH EUDAMED
EMDN Code
W0102030108 CANCER ANTIGEN 242 EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain 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

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

CA 242 Chemiluminescent Immunoassay Kit by Maccura Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Maccura Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000014618
Authorised Representative
Humiss International B.V. NL-AR-000001490

Sources (1)

  • EUDAMED 9f35ee66-e3cb-42a3-a4e9-ea145b62630a 61 fields · synced Jun 18, 2026