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Myoglobin/Troponin I/Creatine Kinase-Myocardial Band (Myo/cTnI/CK-MB) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)

by Jiangsu Confidence Medical Technology Co., Ltd 3 variants

Ref 40 tests/kit, 10 tests/kit, 50 tests/kit, 25 tests/kit

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06979355920742 Basic UDI-DI Date15 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Myoglobin/Troponin I/Creatine Kinase-Myocardial Band (Myo/cTnI/CK-MB) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)
Model / Reference
40 tests/kit, 10 tests/kit, 50 tests/kit, 25 tests/kit
Primary DI / UDI-DI
06979355920742, 06979355920728, 06979355920759, 06979355920735
Basic UDI-DI
B-06979355920742, B-06979355920728, B-06979355920759, B-06979355920735
EMDN Code
W01029099 Immunochemistry reagents - other
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000050949
Authorised representative
JOYSUN GROUP S.L.U ES-AR-000043666

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Properties

  • Sterile YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing

Other properties (7)

  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No