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Devyser Thalassemia v2

by Devyser AB Sweden EUDAMED

Ref 8-R117-24, 8-R117-48 EMDN W0106010111

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7350040638R117RJ Basic UDI-DIDate3 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
8-R117-24, 8-R117-48
Primary DI / UDI-DI
07350040635193, 07350040635209
Basic UDI-DI
7350040638R117RJ
Direct Marketing DI
07350040635193
07350040635209
EMDN Code
W0106010111 Thalassaemia
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 (2)

  • EUDAMED 69468847-556a-4735-b31e-04c67d2a8c40 61 fields · synced 24 Oct 2026
  • EUDAMED 07350040635209|7350040638R117RJ 61 fields · synced 17 May 2026