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mariPOC® Respiratory syncytial virus test reagent

by ArcDia International Oy Ltd EUDAMED

Active European Union

Ref 1R12

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-1R12EJ Basic UDI-DIDate20 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
1R12
Primary DI / UDI-DI
D-1R12EJ
Basic UDI-DI
B-1R12EJ
EMDN Code
W0105040605 Respiratory syncytial virus (rsv)
Device Class
Class IVD General
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000007553

Other devices from ArcDia International Oy Ltd

See all devices from ArcDia International Oy Ltd →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No