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Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 3014129Model 1×100 Tests/kitRef 3021076Model 1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit

by Dirui Industrial Co., Ltd

Identity

Trade Name
Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Device Name
Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Model / Reference
1×100 Tests/kit EUDAMED
3014129 EUDAMED
1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit EUDAMED
3021076 EUDAMED

Identifiers

Primary DI / UDI-DI
06925794518965 EUDAMED
06925794589453 EUDAMED
Basic UDI-DI
B-06925794518965 EUDAMED
69257945W0102030103R0LV EUDAMED
EMDN Code
W0102030103 CANCER ANTIGEN 19-9 EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Class C 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

New Device

No

EUDAMED

Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — 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

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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 (2)

  • EUDAMED 22cb74b6-ebf3-449b-91f1-1cf039f81be6 61 fields · synced Oct 6, 2026
  • EUDAMED 116d6d65-b304-4a3e-887a-cab6fc96c67f 61 fields · synced May 17, 2026