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Prostate Specific Antigen (PSA) Test

by Nantong EgensBiotechnology Co., Ltd. China EUDAMED

Ref strip cassette

EMDN W0102030122

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-693757990607QK Basic UDI-DIDate15 Sep 2023RegisteredStatusActive

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

Model / Reference
strip cassette
Primary DI / UDI-DI
D-693757990607QK
Basic UDI-DI
B-693757990607QK
EMDN Code
W0102030122 Early prostate cancer antigen - 2
Device Class
Class IVD Annex II List B
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000021561
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Nantong EgensBiotechnology Co., Ltd.

See all devices from Nantong EgensBiotechnology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 994eb06a-cfd5-4222-b3e3-9e05f2b69ee0 61 fields · synced 22 Oct 2026