Skip to content

Fluorion

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

Ref M0030102

EMDN W0105010703

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08698898740072 Basic UDI-DIDate13 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 22 Oct 2026

Device Name
Fluorion MTBC QLP 2.1 Real-Time PCR Kit
Model / Reference
M0030102
Primary DI / UDI-DI
08698898740072
Basic UDI-DI
B-08698898740072
EMDN Code
W0105010703 Mycobacterial detection by 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 & 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 1e09061c-8e8d-4ea8-8007-dd7ec77d8af9 61 fields · synced 22 Oct 2026