Skip to content

Multigen

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

Ref M-GAA-01Model FAST-GAA NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile GAA Mutasyonlarını Saptama Kiti EMDN W010699

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8681957090362EC Basic UDI-DIDate14 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
FAST-GAA NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile GAA Mutasyonlarını Saptama Kiti
Model / Reference
FAST-GAA NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile GAA Mutasyonlarını Saptama Kiti, M-GAA-01
Primary DI / UDI-DI
8681957090362EC
Basic UDI-DI
8681957090362EC
Direct Marketing DI
8681957090362EC
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 & 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 321297b8-e87f-4a69-bb76-0363f1cf7c9e 61 fields · synced 22 Oct 2026