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Fluorion

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

Ref M0290202

EMDN W0105030107

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08698898740058 Basic UDI-DIDate27 May 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 23 Oct 2026

Device Name
Fluorion HIV-1 QNP 1.1 Real-Time PCR Kit
Model / Reference
M0290202
Primary DI / UDI-DI
08698898740058
Basic UDI-DI
B-08698898740058
EMDN Code
W0105030107 HIV 1 - na reagents
Device Class
Class IVD Annex II List A
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 & 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 32318780-f02b-4217-86b1-4f0cb193c362 61 fields · synced 23 Oct 2026