Skip to content

Fast Diagnostic Screening Test for Sperm Concentration

by Nantong EgensBiotechnology Co., Ltd. China EUDAMED

Ref JZMD cassetteModel cassette EMDN W0102109013

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-693757990302PS Basic UDI-DIDate11 Sep 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  • Withdrawn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
cassette, JZMD cassette
Primary DI / UDI-DI
D-693757990302PS
Basic UDI-DI
B-693757990302PS
EMDN Code
W0102109013 Sperm antibodies
Device Class
Class IVD devices for self-testing
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
  • Self Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 5079fec3-3088-4dd9-b377-9678c454c427 61 fields · synced 22 Oct 2026