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Multigen

by Multi̇gen Sağlik Hi̇z. Ti̇c. Ltd. Şti̇. EUDAMED

Active European Union

Ref M-HFE-01Model FAST-HFE NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile HFE Mutasyonlarını Saptama Kiti

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8681957090386ES Basic UDI-DIDate14 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
FAST-HFE NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile HFE Mutasyonlarını Saptama Kiti
Model / Reference
FAST-HFE NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile HFE Mutasyonlarını Saptama Kiti, M-HFE-01
Primary DI / UDI-DI
8681957090386ES
Basic UDI-DI
8681957090386ES
Direct Marketing DI
8681957090386ES
EMDN Code
W010699 Genetic tests - other
Device Class
Class C
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000050129

Other devices from Multi̇gen Sağlik Hi̇z. Ti̇c. Ltd. Şti̇.

See all devices from Multi̇gen Sağlik Hi̇z. Ti̇c. Ltd. Şti̇. →

Properties

  • Microbial Substances
  • Reagent
  • New Device

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No