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PSA and fPSA Rapid Test Kit

by Shenzhen Lvshiyuan Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref A26031007

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974169670074 Basic UDI-DIDate12 May 2026RegisteredStatusActive

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  • Withdrawn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
A26031007
Primary DI / UDI-DI
06974169670074
Basic UDI-DI
B-06974169670074
EMDN Code
W0102030199 Cancer antigens - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000028164
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Shenzhen Lvshiyuan Biotechnology Co., Ltd.

See all devices from Shenzhen Lvshiyuan Biotechnology Co., Ltd. →

Properties

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