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SERATEC PSA Semiquant TM

by SERATEC Gesellschaft für Biotechnologie mbH Germany EUDAMED

Ref PSM400T EMDN W0102160299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-DE-MF000031456MB Basic UDI-DIDate19 May 2025RegisteredStatusActive

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  • Withdrawn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
PSM400T
Primary DI / UDI-DI
D-DE-MF000031456MB
Basic UDI-DI
B-DE-MF000031456MB
EMDN Code
W0102160299 Tumour marker rt & poc - other
Device Class
Class IVD Annex II List B
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
DE-MF-000031456

Other devices from SERATEC Gesellschaft für Biotechnologie mbH

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 2e13420a-794f-4657-a730-bcfb7877d99b 61 fields · synced 22 Oct 2026