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geneMAP

by Genmark Sağlik Ürünleri̇ İthalat İhracat Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED

Ref THR6-RT50

EMDN W0106010115

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-TRMF000028405THR6RT50HP Basic UDI-DIDate25 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
geneMAP Thrombophilia P., 50T (FII, FVL,MTHFR677, MTHFR1298, PAI,FXIII)
Model / Reference
THR6-RT50
Primary DI / UDI-DI
D-TRMF000028405THR6RT50HP
Basic UDI-DI
B-TRMF000028405THR6RT50HP
EMDN Code
W0106010115 Combined factor ii / factor v leiden
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000028405

Other devices from Genmark Sağlik Ürünleri̇ İthalat İhracat Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Genmark Sağlik Ürünleri̇ İthalat İhracat Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED a323f5e5-9455-49f4-8668-a0fe980d9ee9 61 fields · synced 24 Oct 2026