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AFIAS PSA Neo

by Boditech Med Inc. South Korea EUDAMED

Ref SMFP-130Model AFIAS PSA Neo EMDN W0102030113

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880613300621C9 Basic UDI-DIDate29 Jun 2026RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Model / Reference
AFIAS PSA Neo, SMFP-130
Primary DI / UDI-DI
08806133043653
Basic UDI-DI
880613300621C9
EMDN Code
W0102030113 Total prostatic specific antigen
Device Class
Class C
Market of Registration
Germany

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 (1)

  • EUDAMED 08806133043653|880613300621C9 61 fields · synced 24 Oct 2026