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Enhanced IntRaFast-Q SMA Screening Kit

by Snp Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Ve Üreti̇m Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇li̇mi̇ted Türkiye EUDAMED

Ref 200R-60-01 EMDN W0106010199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08680422281595 Basic UDI-DIDate15 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
200R-60-01
Primary DI / UDI-DI
08680422281595
Basic UDI-DI
B-08680422281595
EMDN Code
W0106010199 Monogenetic disorders tests - other
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000036548

Other devices from Snp Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Ve Üreti̇m Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇li̇mi̇ted

See all devices from Snp Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Ve Üreti̇m Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇li̇mi̇ted →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 08680422281595|B-08680422281595 61 fields · synced 25 Oct 2026