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Cardiac Troponin I Detection Kit

by HRJ Biotech Medical Co Ltd

Ref F66025Model 25 Cartridges

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975937420426 Basic UDI-DI 06975937420426UDI-DIDate14 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
25 Cartridges, F66025
Primary DI / UDI-DI
06975937420426
Basic UDI-DI
B-06975937420426
EMDN Code
W0102160703 Troponin i/t - rt & poc
Device Class
Class IVD General
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000058400
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from HRJ Biotech Medical Co Ltd

See all devices from HRJ Biotech Medical Co Ltd →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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