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Yeni Nesil Dizi Analizi ile BRCA1 ve BRCA2 Mutasyonlarını Saptama Kiti

by Multi̇gen Sağlik Hi̇z. Ti̇c. Ltd. Şti̇.

Ref M-BR-01Model BRCA1 ve BRCA2 Mutasyonlarını Saptama Kiti

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number8681957090MLTGNNZ Basic UDI-DI 8681957090034DQUDI-DIDate13 May 2026RegisteredStatusActive
European UnionCE/IVDR Number8681957090MLTGNNZ Basic UDI-DI 8681957090034DQUDI-DIDate13 May 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Trade Name
Multigen
Device Name
Yeni Nesil Dizi Analizi ile BRCA1 ve BRCA2 Mutasyonlarını Saptama Kiti
Model / Reference
BRCA1 ve BRCA2 Mutasyonlarını Saptama Kiti, M-BR-01
Primary DI / UDI-DI
8681957090034DQ
Basic UDI-DI
8681957090MLTGNNZ, B-8681957090034DQ
EMDN Code
W01060203 Brca 1+2
Device Class
Class C
Class IVD General
EU 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

  • Reagent

Other properties (10)

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