Skip to content

geneMAP

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

Ref BCRSCR-RT48

EMDN W01060208

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-TRMF000028405BCRSCRRTF7 Basic UDI-DIDate26 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 23 Oct 2026

Device Name
geneMAP BCR-ABL1 (p190, p210, p230) Screening Kit, 48T
Model / Reference
BCRSCR-RT48
Primary DI / UDI-DI
D-TRMF000028405BCRSCRRTF7
Basic UDI-DI
B-TRMF000028405BCRSCRRTF7
EMDN Code
W01060208 T (9;22)
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 3cc6b81b-a3b4-437a-aba3-4d751730996d 61 fields · synced 23 Oct 2026