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Free Prostate Specific Antigen (f-PSA) Diagnostic Kit

by Shenzhen Microprofit Biotech Co., Ltd EUDAMED

Active European Union

Ref MF-47-20

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06971348760113 Basic UDI-DIDate12 Jul 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
MF-47-20
Primary DI / UDI-DI
06971348760113
Basic UDI-DI
B-06971348760113
EMDN Code
W0102030114 Free prostatic specific antigen
Device Class
Class IVD Annex II List B
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000019518
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

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