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High-Sensitivity C-reactive Protein ( Electrochemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 689012Model 2×100TModel 50T, 2x50T, 100T, 2x100T

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name
High-Sensitivity C-reactive Protein ( Electrochemiluminescence Immunoassay) EUDAMED
Device Name
High-Sensitivity C-reactive Protein ( Electrochemiluminescence Immunoassay) EUDAMED
Model / Reference
2×100T EUDAMED
689012 EUDAMED
50T, 2x50T, 100T, 2x100T EUDAMED

Identifiers

Primary DI / UDI-DI
06970341681036 EUDAMED
Basic UDI-DI
B-06970341681036 EUDAMED
69703416803205029JK EUDAMED
EMDN Code
W01021308 HIGH-SENSITIVITY C-.REACTIVE PROTEIN 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

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

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

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

Sources (2)

  • EUDAMED 18740147-0777-4ee3-bd09-9e17f8478506 61 fields · synced Jul 26, 2026
  • EUDAMED b5a1ebdb-6a51-495e-ba72-ed5ec13e50f6 61 fields · synced May 17, 2026