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Chemiluminescent Immunoassay Assay Kits for Free Prostate Specific Antigen (t-PSA)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EIM4407106Model total PSA (CLIA)

EMDN W0102030113

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-EIM4407106GJ Basic UDI-DIDate22 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Chemiluminescent Immunoassay Assay Kits for Free Prostate Specific Antigen (t-PSA)
Model / Reference
total PSA (CLIA), EIM4407106
Primary DI / UDI-DI
D-EIM4407106GJ
Basic UDI-DI
B-EIM4407106GJ
EMDN Code
W0102030113 Total prostatic specific antigen
Device Class
Class IVD Annex II List B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED c13dc7c1-30f0-4a3b-8450-60e248be92f0 61 fields · synced 22 Oct 2026