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Devyser Cftr

by Devyser AB Sweden EUDAMED

Ref 8-R101-24

EMDN W0106010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7350040638R101R3 Basic UDI-DIDate30 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
8-R101-24
Primary DI / UDI-DI
07350040632161
Basic UDI-DI
7350040638R101R3
Direct Marketing DI
07350040632161
EMDN Code
W0106010101 Cystic fibrosis
Device Class
Class C
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000001699

Other devices from Devyser AB

See all devices from Devyser AB →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
  • New Device
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 7919b0c1-31ed-4bc4-8326-9aa1f279a7c4 61 fields · synced 24 Oct 2026