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Cancer Antigen 72-4 (eCLIA)

EUDAMED

Class IVD General (EU MDR)

Ref 0320501702Model 2×50 TModel : 50T, 2×50T, 100T, 2×100T

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name
Cancer Antigen 72-4 (eCLIA) EUDAMED
Device Name
Cancer Antigen 72-4 (eCLIA) EUDAMED
Model / Reference
2×50 T EUDAMED
0320501702 EUDAMED
: 50T, 2×50T, 100T, 2×100T EUDAMED

Identifiers

Primary DI / UDI-DI
06975984063577 EUDAMED
Basic UDI-DI
B-06975984063577 EUDAMED
69703416803205052JE EUDAMED
EMDN Code
W0102030105 CANCER ANTIGEN 72-4 EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Class C EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

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 72-4 (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

European Union Active

CE/IVDD

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Manufacturer

EUDAMED SRN
CN-MF-000005654
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED d90b9c0b-6d26-4e91-97bc-7612e4c3ae57 61 fields · synced Sep 18, 2026
  • EUDAMED 29380c73-eeba-4c34-b898-30506148f2d7 61 fields · synced May 18, 2026