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RevoDx HBV qPCR Kit

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

Ref IP201901-100, IP201901-50 EMDN W0105020216

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08683079717240 Basic UDI-DIDate28 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
IP201901-100, IP201901-50
Primary DI / UDI-DI
08683079717240, 08683079717233
Basic UDI-DI
B-08683079717240, B-08683079717233
EMDN Code
W0105020216 Hepatitis b virus - na reagents
Device Class
Class IVD General
Market of Registration
Türkiye
Austria

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 (2)

  • EUDAMED aa9fae40-11ea-4d4e-b070-46bef2042333 61 fields · synced 22 Oct 2026
  • EUDAMED 08683079717233|B-08683079717233 61 fields · synced 19 May 2026