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IntRaFast-Q SMA SCREENING KIT

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

Ref 200R-40-01 EMDN W0106010199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-86804222814035R Basic UDI-DIDate18 Jul 2023RegisteredStatusActive

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  • Withdrawn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-40-01
Primary DI / UDI-DI
D-86804222814035R, 08680422281403
Basic UDI-DI
B-86804222814035R, B-08680422281403
EMDN Code
W0106010199 Monogenetic disorders tests - other
Device Class
Class IVD General
Market of Registration
Italy
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 NoEUDAMEDYesEUDAMED
  • 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 (2)

  • EUDAMED 9d387a18-8ca5-4937-8237-bf3dd2e724d0 61 fields · synced 22 Oct 2026
  • EUDAMED 08680422281403|B-08680422281403 61 fields · synced 25 Oct 2026