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Fluorion

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

Active European Union

Ref M0610202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08698898740508 Basic UDI-DIDate20 Jun 2022RegisteredStatusActive

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  • Withdrawn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

Device Name
Fluorion BKV QNP 1.0 Real-Time PCR Kit
Model / Reference
M0610202
Primary DI / UDI-DI
08698898740508
Basic UDI-DI
B-08698898740508
EMDN Code
W0105040522 Bk virus - na reagents
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000023054

Other devices from Iontek Ilac Tani Ve Biyoteknoloji Urunleri Ar. Ge. San. Tic. A.S.

See all devices from Iontek Ilac Tani Ve Biyoteknoloji Urunleri Ar. Ge. San. Tic. A.S. →

Properties

  • 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