Carbonhydrate Antigen 19-9 (eCLIA)

EUDAMED

Class C (EU MDR)

Ref 06970341685805Model 50T, 2×50T, 100T ,2×100TRef 0320500801Model 50 T

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name: Carbonhydrate Antigen 19-9 (eCLIA) EUDAMED
Carbohydrate Antigen 19-9 (eCLIA) EUDAMED
Device Name: Carbonhydrate Antigen 19-9 (eCLIA) EUDAMED
Carbohydrate Antigen 19-9 (eCLIA) EUDAMED
Model / Reference: 50T, 2×50T, 100T ,2×100T EUDAMED
06970341685805 EUDAMED
50 T EUDAMED
0320500801 EUDAMED

Identifiers

Primary DI / UDI-DI: 06970341685805 EUDAMED
Basic UDI-DI: 69703416803205024J9 EUDAMED
B-06970341685805 EUDAMED
EMDN Code: W0102030103 CANCER ANTIGEN 19-9 EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Carbonhydrate Antigen 19-9 (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	69703416803205024J9	Class C	Active
EUDAMED	European Union	CE/IVDR	69703416803205024J9	Class C	Active

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Manufacturer

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
EUDAMED SRN: CN-MF-000005654
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

EUDAMED 48d4dc87-fd5a-4056-862f-f3b655bac558 61 fields · synced Jul 28, 2026
EUDAMED 3a97e8dd-4902-4047-8a62-d14ff2b0b9a8 61 fields · synced May 18, 2026