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Reagena C6 LYME IgM/IgG EIA

by Reagena Oy Finland EUDAMED

Ref 114403 EMDN W0105010602

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-114403M5 Basic UDI-DIDate18 Dec 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
114403
Primary DI / UDI-DI
D-114403M5
Basic UDI-DI
B-114403M5
EMDN Code
W0105010602 Lyme antibody total
Device Class
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
  • Human Tissues
  • Animal Tissues
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 97df4995-2d22-419e-89eb-d7b6f534a839 61 fields · synced 25 Oct 2026