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Afias-1

by Boditech Med Inc. South Korea EUDAMED

Ref FPRR019Model AFIAS-1

EMDN W0201020201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880613301005BL Basic UDI-DIDate4 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
AFIAS-1, FPRR019
Primary DI / UDI-DI
08806133010051
Basic UDI-DI
880613301005BL
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
Market of Registration
Lithuania

Manufacturer details

EUDAMED SRN
KR-MF-000011028
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Boditech Med, Inc.

See all devices from Boditech Med, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 08806133010051|880613301005BL 61 fields · synced 25 Oct 2026