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RevoDx HCV qPCR Kit

by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. Türkiye EUDAMED

Ref IP201903-100, IP202325-25, IP201903-50, IP202325-50

EMDN W0105020307

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08684387212021 Basic UDI-DIDate28 Apr 2026RegisteredStatusActive

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

Trade Name
RevoDx HCV qPCR Kit
RevoDx HCV Genotyping qPCR Kit v01
Model / Reference
IP201903-100, IP202325-25, IP201903-50, IP202325-50
Primary DI / UDI-DI
08684387212021, 08684387212144, 08684387212014, 08684387212151
Basic UDI-DI
B-08684387212021, B-08684387212144, B-08684387212014, B-08684387212151
EMDN Code
W0105020307, W0105020309
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000047330

Other devices from İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.

See all devices from İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. →

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 (4)

  • EUDAMED b996afaa-a1f3-4b53-8954-2714c71a7ad2 61 fields · synced 22 Oct 2026
  • EUDAMED 08684387212144|B-08684387212144 61 fields · synced 18 May 2026
  • EUDAMED 08684387212014|B-08684387212014 61 fields · synced 18 May 2026
  • EUDAMED 08684387212151|B-08684387212151 61 fields · synced 19 May 2026