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Afias Bnp

by Boditech Med Inc. South Korea EUDAMED

Ref SMFP-83Model AFIAS BNP

EMDN W01021301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number880613300572CM Basic UDI-DIDate26 Jun 2026RegisteredStatusActive
European UnionCE/IVDR Number880613300572CM Basic UDI-DIDate26 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
AFIAS BNP, SMFP-83
Primary DI / UDI-DI
08806133043400, 08806133005729
Basic UDI-DI
880613300572CM, B-08806133005729
EMDN Code
W01021301 Bnp / probnp (including other natriuric peptides)
Device Class
Class C
Class IVD General
Market of Registration
Netherlands
Italy

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
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 30c73940-4fc3-4ff1-9e6b-a88fac608446 61 fields · synced 22 Oct 2026
  • EUDAMED 08806133005729|B-08806133005729 61 fields · synced 24 Oct 2026