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ReaScan TBE IgM

by Reagena Oy Finland EUDAMED

Ref 114106, 105100

EMDN W0105099099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number643007445114106A7 Basic UDI-DIDate24 Sep 2025RegisteredStatusActive
European UnionCE/IVDR Number643007445114106A7 Basic UDI-DIDate24 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
ReaScan TBE IgM
ReaScan+
Device Name
ReaScan+ reader
Model / Reference
114106, 105100
Primary DI / UDI-DI
06430074452469, 06430074450007, D-114106LU
Basic UDI-DI
643007445114106A7, 6430074451051009P, B-114106LU
Direct Marketing DI
06430074450007
EMDN Code
W0105099099, W0299
Device Class
Class B
Class A
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 YesEUDAMEDNoEUDAMED
  • Professional Testing
  • Surgical Instrument NoEUDAMEDYesEUDAMED
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (3)

  • EUDAMED e5f145d2-2654-42f7-9716-1a8bed0b7d5e 61 fields · synced 22 Oct 2026
  • EUDAMED 06430074450007|6430074451051009P 61 fields · synced 19 May 2026
  • EUDAMED D-114106LU|B-114106LU 61 fields · synced 19 May 2026