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Fluorion

by Iontek Ilac Tani Ve Biyoteknoloji Urunleri Ar. Ge. San. Tic. A.S. Türkiye EUDAMED

Ref M0020202

EMDN W0105020307

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08698898740027 Basic UDI-DIDate20 Jun 2022RegisteredStatusActive

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

Device Name
Fluorion HCV QNP 2.1 Real-Time PCR
Model / Reference
M0020202
Primary DI / UDI-DI
08698898740027
Basic UDI-DI
B-08698898740027
EMDN Code
W0105020307 Hepatitis c virus - na reagents
Device Class
Class IVD Annex II List A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000023054

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 f5cbeb79-094f-4694-966b-35eec48b4801 61 fields · synced 22 Oct 2026