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High-Sensitivity C-reactive Protein ( Electrochemiluminescence Immunoassay)

EUDAMED

Class C (EU MDR)

Ref 0320501402Model 50T, 2x50T, 100T, 2x100TModel 2×50T

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name
High-Sensitivity C-reactive Protein ( Electrochemiluminescence Immunoassay) EUDAMED
Alpha-Fetoprotein (eCLIA) EUDAMED
Device Name
Alpha-Fetoprotein (eCLIA) EUDAMED
Model / Reference
50T, 2x50T, 100T, 2x100T EUDAMED
0320501402 EUDAMED
2×50T EUDAMED

Identifiers

Primary DI / UDI-DI
06975984063362 EUDAMED
Basic UDI-DI
69703416803205048JP EUDAMED
B-06975984063362 EUDAMED
EMDN Code
W01021308 HIGH-SENSITIVITY C-.REACTIVE PROTEIN EUDAMED
W0102039001 ALPHAFETOPROTEIN EUDAMED

Classification

Device Class
Class C EUDAMED
Class IVD General 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

High-Sensitivity C-reactive Protein ( Electrochemiluminescence Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class C — IVDD, IVDR — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

European Union Active

CE/IVDR

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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 46a8739e-d59d-4d53-b44b-51c8e98eed4c 61 fields · synced Jun 18, 2026
  • EUDAMED 188e61b0-050e-47ed-9c1a-f8b39dcca39d 61 fields · synced May 18, 2026