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Reastain Urine

by Reagena Oy Finland EUDAMED

Ref 140345

EMDN W0103010301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number643007445140345AY Basic UDI-DIDate23 May 2022RegisteredStatusActive

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
140345
Primary DI / UDI-DI
06430074450151
Basic UDI-DI
643007445140345AY
EMDN Code
W0103010301 Histo / cyto stains
Device Class
Class A
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
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 1699eeb9-a61f-4708-a6f6-2a4ea4cdeb15 61 fields · synced 22 Oct 2026