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Multigen

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

Ref M-CDH1-01 EMDN W010699

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8681957090201DK Basic UDI-DIDate13 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  • Withdrawn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 24 Oct 2026

Device Name
FAST-TP53 Yeni Nesil Dizi Analizi ile TP53 Mutasyonlarını Saptama Kiti
Model / Reference
M-CDH1-01
Primary DI / UDI-DI
8681957090188EL
Basic UDI-DI
8681957090201DK
Direct Marketing DI
8681957090188EL
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
  • 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 166d30b8-02ee-48b5-9ce6-16a0bf8c3011 61 fields · synced 24 Oct 2026