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Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)

EUDAMED

Class IVD General (EU MDR)

Ref 50 tests/kit Model 50 tests/kit Ref 100 tests/kitRef 25 tests/kitModel 25 tests/kit

by Wuhan Life Origin Biotech Joint Stock Co., Ltd.

Identity

Trade Name
Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography) EUDAMED
Device Name
Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography) EUDAMED
Model / Reference
50 tests/kit EUDAMED
100 tests/kit EUDAMED
25 tests/kit EUDAMED

Identifiers

Primary DI / UDI-DI
06974986813777 EUDAMED
06974986813784 EUDAMED
06974986813760 EUDAMED
Basic UDI-DI
B-06974986813777 EUDAMED
B-06974986813784 EUDAMED
B-06974986813760 EUDAMED
EMDN Code
W01021399 CARDIAC MARKERS - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

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

Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography) by Wuhan Life Origin Biotech Joint Stock 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
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
EUDAMED SRN
CN-MF-000027340
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (3)

  • EUDAMED 5f9b2112-e985-4b88-9ede-88bada2f57ab 61 fields · synced Oct 7, 2026
  • EUDAMED bd6ee797-2557-4b54-8e3c-ed3fa5f36273 61 fields · synced May 18, 2026
  • EUDAMED 25e391f0-9e8d-4a8d-98fc-dbb6413b277c 61 fields · synced May 18, 2026