Skip to content

Total Prostate-Specific Antigen Assay Kit (Immunochromatographic Assay)

by Wuhan Life Origin Biotech Joint Stock Co., Ltd. China EUDAMED

Ref 50 tests/kit EMDN W0102030113

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974986813937 Basic UDI-DIDate18 Dec 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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
50 tests/kit
Primary DI / UDI-DI
06974986813937
Basic UDI-DI
B-06974986813937
EMDN Code
W0102030113 Total prostatic specific antigen
Device Class
Class IVD General
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000027340
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wuhan Life Origin Biotech Joint Stock Co., Ltd.

See all devices from Wuhan Life Origin Biotech Joint Stock Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 78cbd4e8-2a86-46c5-8058-834efb7a00be 61 fields · synced 22 Oct 2026