Creatine Kinase MB (Electrochemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 691018Model 2×100TModel 50T, 2×50T, 100T, 2×100T

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name: Creatine Kinase MB (Electrochemiluminescence Immunoassay) EUDAMED
Device Name: Creatine Kinase MB (Electrochemiluminescence Immunoassay) EUDAMED
Model / Reference: 2×100T EUDAMED
691018 EUDAMED
50T, 2×50T, 100T, 2×100T EUDAMED

Identifiers

Primary DI / UDI-DI: 06970341680961 EUDAMED
Basic UDI-DI: B-06970341680961 EUDAMED
69703416803205033JA EUDAMED
EMDN Code: W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Class C 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

Creatine Kinase MB (Electrochemiluminescence Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	B-06970341680961	Class IVD General	Active
EUDAMED	European Union	CE/IVDD	B-06970341680961	Class IVD General	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 6f2c887e-dcbd-4b0f-859c-88c4f722659d 61 fields · synced Jun 18, 2026
EUDAMED 3612129f-6975-4c4f-a105-499de67d1781 61 fields · synced May 19, 2026