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Stentil

by Hubei MEIBAO Biotechnology Co., Ltd EUDAMED

Active European Union

Ref HCG-M35AModel Midstream

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06957290301253 Basic UDI-DIDate24 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
One Step HCG Pregnancy Test
Model / Reference
Midstream, HCG-M35A
Primary DI / UDI-DI
06957290301253
Basic UDI-DI
B-06957290301253
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000019986
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Hubei MEIBAO Biotechnology Co., Ltd

See all devices from Hubei MEIBAO Biotechnology Co., Ltd →

Properties

  • Reagent
  • Self Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No