High-Sensitivity C-reactive Protein ( Electrochemiluminescence Immunoassay)

EUDAMED

Class C (EU MDR)

Ref 689020Model 50T, 2x50T, 100T, 2x100TModel 2×50T

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: 50T, 2x50T, 100T, 2x100T EUDAMED
689020 EUDAMED
2×50T EUDAMED

Identifiers

Primary DI / UDI-DI: 06975984063041 EUDAMED
Basic UDI-DI: 69703416803205029JK EUDAMED
B-06975984063041 EUDAMED
EMDN Code: W01021308 HIGH-SENSITIVITY C-.REACTIVE PROTEIN 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

Yes

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

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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	69703416803205029JK	Class C	Active
EUDAMED	European Union	CE/IVDR	69703416803205029JK	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 ebbc7f20-e0ca-4e98-b12f-f469923cb9ec 61 fields · synced Jul 19, 2026
EUDAMED b951b82e-e683-498a-84a4-787111eebd6e 61 fields · synced May 19, 2026