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hepatomiR kit

by TAmiRNA GmbH Austria EUDAMED

Ref KT-031-HEP

EMDN W01010499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-HEPATOMIRRL Basic UDI-DIDate14 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
KT-031-HEP
Primary DI / UDI-DI
D-HEPATOMIRRL
Basic UDI-DI
B-HEPATOMIRRL
EMDN Code
W01010499 Multiple clin. chem lab reagents - other
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000028544

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED f82251dc-ffd2-4c14-b688-660b482fc766 61 fields · synced 22 Oct 2026