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Sema Protect

by Nantong EgensBiotechnology Co., Ltd. China EUDAMED

Ref HCG-CModel cassette

EMDN W0102160302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06937579911137 Basic UDI-DIDate3 Jun 2026RegisteredStatusActive

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 24 Oct 2026

Device Name
Test ciążowy hCG płytkowy SEMA PROTECT
Model / Reference
cassette, HCG-C
Primary DI / UDI-DI
06937579911137
Basic UDI-DI
B-06937579911137
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Poland

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
  • Surgical Instrument
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 06937579911137|B-06937579911137 61 fields · synced 24 Oct 2026