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Creatine Kinase MB STAT (CK-MB STAT) eCLIA

EUDAMED

Class C (EU MDR)

Ref 691042Model 50T, 2×50T, 100T, 2×100TRef 691041Model 50T

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name
Creatine Kinase MB STAT (CK-MB STAT) eCLIA EUDAMED
Device Name
Creatine Kinase MB STAT (CK-MB STAT) eCLIA EUDAMED
Model / Reference
50T, 2×50T, 100T, 2×100T EUDAMED
691042 EUDAMED
691041 EUDAMED
50T EUDAMED

Identifiers

Primary DI / UDI-DI
06975984063287 EUDAMED
06970341689346 EUDAMED
Basic UDI-DI
69703416803205034JC EUDAMED
B-06970341689346 EUDAMED
EMDN Code
W01021311 CREATINE KINASE - MB MASS (IC) 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

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

Creatine Kinase MB STAT (CK-MB STAT) 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

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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 (3)

  • EUDAMED bb8ef21c-4bf6-4fb5-8e62-e5aa824dc6d5 61 fields · synced Aug 3, 2026
  • EUDAMED e397bca6-fe09-417d-aa1c-79e4a65fa9d1 61 fields · synced May 17, 2026
  • EUDAMED b74cc87d-84f5-4db3-b77e-314baa0c4575 61 fields · synced Aug 3, 2026