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High-sensitivity Cardiac Troponin I (hs-cTnI) Quantitative Test (Quantum Dot Fl…

EUDAMED

Class IVD General (EU MDR)

Ref GKPD054Model 25 tests/kitRef A6403CVRef A6402CVModel A6402CL, A6403CV, A6402CV, A6402CC, A6404CC, A6403CC

by Dezhou Guoke Medical Technology Co., Ltd.

Identity

Trade Name
High-sensitivity Cardiac Troponin I (hs-cTnI) Quantitative Test (Quantum Dot Fluorescence Immunochromatography) EUDAMED
High Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Quantum Dots Fluorescence Immunochromatography) EUDAMED
Device Name
High-sensitivity Cardiac Troponin I (hs-cTnI) Quantitative Test (Quantum Dot Fluorescence Immunochromatography) EUDAMED
High Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Quantum Dots Fluorescence Immunochromatography) EUDAMED
Model / Reference
25 tests/kit EUDAMED
GKPD054 EUDAMED
A6403CV EUDAMED
A6402CL, A6403CV, A6402CV, A6402CC, A6404CC, A6403CC EUDAMED
A6402CV EUDAMED

Identifiers

Primary DI / UDI-DI
06977698402789 EUDAMED
06973315737005 EUDAMED
06973315736909 EUDAMED
Basic UDI-DI
B-06977698402789 EUDAMED
B-06973315737005 EUDAMED
B-06973315736909 EUDAMED
EMDN Code
W0102160706 MULTIPLE CARDIAC MARKERS - RT & POC EUDAMED
W01021306 TROPONIN I/T EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMEDEUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMEDEUDAMED

Professional Testing

Yes

EUDAMEDEUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

High-sensitivity Cardiac Troponin I (hs-cTnI) Quantitative Test (Quantum Dot Fl… by Dezhou Guoke Medical Technology Co., Ltd. — Class IVD General — IVDD…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Dezhou Guoke Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000044128
Authorised Representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Sources (3)

  • EUDAMED 23c631d3-55c7-49cd-b793-321ca3542081 61 fields · synced Jul 24, 2026
  • EUDAMED 9bdb2c9a-a283-4a41-afb0-2cf807a81dc8 61 fields · synced Jul 17, 2026
  • EUDAMED 4a042ea7-92c0-42c6-9d14-9f01124d3267 61 fields · synced Jul 24, 2026