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Fortel Prostate (PSA) Screening Test

by BIOEUROPE GmbH Germany EUDAMED

Ref 1081-1 EMDN W0102160202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-1081-1LS Basic UDI-DIDate13 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
1081-1
Primary DI / UDI-DI
D-1081-1LS
Basic UDI-DI
B-1081-1LS
EMDN Code
W0102160202 Psa - rt & poc
Device Class
Class IVD Annex II List B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000039230

Other devices from BIOEUROPE GmbH

See all devices from BIOEUROPE GmbH →

Properties & raw data

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

Sources (1)

  • EUDAMED fffd53e6-60db-4511-a3d5-bea0ac43f147 61 fields · synced 22 Oct 2026