Skip to content

ReaScan+ PUUMALA IgM

by Reagena Oy Finland EUDAMED

Ref 115105 EMDN W0105099099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number643007445115105AC Basic UDI-DIDate24 Sep 2025RegisteredStatusActive
European UnionCE/IVDR Number643007445115105AC Basic UDI-DIDate24 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
115105
Primary DI / UDI-DI
06430074452452, D-115105LZ
Basic UDI-DI
643007445115105AC, B-115105LZ
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class B
Class IVD General
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000002804

Other devices from Reagena Oy

See all devices from Reagena Oy →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED a8f18745-ff14-48a1-97c2-f3108822b13b 61 fields · synced 22 Oct 2026
  • EUDAMED D-115105LZ|B-115105LZ 61 fields · synced 17 May 2026