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Multi Control Cardiac Marker

EUDAMED

Class IVD General (EU MDR)

Ref 691028Model Low value: 6 x 2 mL, high value: 6 x 2 mLModel Low value: 3 × 2.0 mL, High value: 3 × 2.0 mL; Low value: 6 × 2.0 mL, High value: 6 × 2.0 mL

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name
Multi Control Cardiac Marker EUDAMED
Device Name
Multi Control Cardiac Marker EUDAMED
Model / Reference
Low value: 6 x 2 mL, high value: 6 x 2 mL EUDAMED
691028 EUDAMED
Low value: 3 × 2.0 mL, High value: 3 × 2.0 mL; Low value: 6 × 2.0 mL, High value: 6 × 2.0 mL EUDAMED

Identifiers

Primary DI / UDI-DI
06970341680565 EUDAMED
Basic UDI-DI
B-06970341680565 EUDAMED
6970341680320500701LJ EUDAMED
EMDN Code
W0102152004 CARDIAC MARKER CONTROLS 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

Multi Control Cardiac Marker by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS

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 84bd2a06-b7bd-453c-8262-8342407357ff 61 fields · synced Aug 2, 2026
  • EUDAMED 6fdf61c6-cc86-4f38-9403-1fa85991815b 61 fields · synced May 19, 2026