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Pregnancy Test for Self Testing

by Nantong EgensBiotechnology Co., Ltd. China EUDAMED

Ref HCG strip cassetteModel strip cassette EMDN W0102160302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-693757990101PE Basic UDI-DIDate8 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  • Withdrawn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
strip cassette, HCG strip cassette
Primary DI / UDI-DI
D-693757990101PE
Basic UDI-DI
B-693757990101PE
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
France

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
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 9a0b59b6-84d1-4b24-a498-1593bcf456b1 61 fields · synced 22 Oct 2026