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mariPOC® System solution

by ArcDia International Oy Ltd Finland EUDAMED

Ref B05 EMDN W0599

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number643008037B059N Basic UDI-DIDate6 Dec 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
B05
Primary DI / UDI-DI
06430080370382
Basic UDI-DI
643008037B059N
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
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 & 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 85aa292b-8d47-42cc-b3ac-0a7afb5279a6 61 fields · synced 22 Oct 2026