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Advyser Solid Organs

by Devyser AB Sweden EUDAMED

Ref 8-R116

EMDN W02050392

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7350040638R116RG Basic UDI-DIDate13 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
8-R116
Primary DI / UDI-DI
07350040631881
Basic UDI-DI
7350040638R116RG
Direct Marketing DI
07350040631881
EMDN Code
W02050392 Nucleic acid testing instruments - rapid and point of care tests - IVD medical device software
Device Class
Class C
Special Device Type
Software
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
  • Professional Testing
  • New Device
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 c1948412-6066-4602-bc73-0ad5b3b74f6b 61 fields · synced 22 Oct 2026