Skip to content

hs-cTnI Fast Test Kit (Immunofluorescence Assay)

by Getein Biotech, Inc. EUDAMED

Active European Union

Ref IF5019

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number695441470223H2 Basic UDI-DIDate4 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

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.

Specification

EUDAMED

Model / Reference
IF5019
Primary DI / UDI-DI
06954414722024
Basic UDI-DI
695441470223H2
EMDN Code
W01021306 Troponin i/t
Device Class
Class C
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000017986
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Getein Biotech, Inc

See all devices from Getein Biotech, Inc →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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