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Multi̇gen

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

Ref M-CF-01Model Yeni Nesil Dizi Analizi ile CFTR Mutasyonlarını Saptama Kiti

EMDN W0106010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8681957090041DM Basic UDI-DIDate13 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
Yeni Nesil Dizi Analizi ile CFTR Mutasyonlarını Saptama Kiti
Model / Reference
Yeni Nesil Dizi Analizi ile CFTR Mutasyonlarını Saptama Kiti, M-CF-01
Primary DI / UDI-DI
8681957090041DM
Basic UDI-DI
8681957090041DM
Direct Marketing DI
8681957090041DM
EMDN Code
W0106010101 Cystic fibrosis
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
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED f89a6347-6c02-4556-b05a-6f74ab180442 61 fields · synced 22 Oct 2026