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Multigen

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

Ref M-GLA-01Model FAST-GLA Yeni Nesil Dizi Analizi ile GLA Mutasyonlarını Saptama Kiti

EMDN W010699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8681957090325E6 Basic UDI-DIDate14 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
FAST-GLA Yeni Nesil Dizi Analizi ile GLA Mutasyonlarını Saptama Kiti
Model / Reference
FAST-GLA Yeni Nesil Dizi Analizi ile GLA Mutasyonlarını Saptama Kiti, M-GLA-01
Primary DI / UDI-DI
8681957090325E6
Basic UDI-DI
8681957090325E6
Direct Marketing DI
8681957090325E6
EMDN Code
W010699 Genetic tests - other
Device Class
Class C
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000050129

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 0f46e929-065d-4dbf-8b5d-acec64c1e010 61 fields · synced 22 Oct 2026