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ichroma™ PSA Neo

by Boditech Med Inc. EUDAMED

Active European Union

Ref CFPC-157Model ichroma™ PSA Neo

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880613300133BP Basic UDI-DIDate2 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
ichroma™ PSA Neo, CFPC-157
Primary DI / UDI-DI
08806133043585
Basic UDI-DI
880613300133BP
EMDN Code
W0102030113 Total prostatic specific antigen
Device Class
Class C
Market of Registration
Austria

Manufacturer details

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

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Properties

  • 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