Skip to content

Free Prostate Specific Antigen (f-PSA) Determination Kit (Chemiluminescence Immunoassay)

by Shenzhen Channel Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref CR058EU01Model 10 Tests/Kit or 20 Tests/Kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976968300398 Basic UDI-DIDate27 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  • Withdrawn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
10 Tests/Kit or 20 Tests/Kit, CR058EU01
Primary DI / UDI-DI
06976968300398
Basic UDI-DI
B-06976968300398
EMDN Code
W0102030114 Free prostatic specific antigen
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000053778
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Shenzhen Channel Biotechnology Co., Ltd.

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

Properties

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