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Romed

by Hubei MEIBAO Biotechnology Co., Ltd EUDAMED

Active European Union

Ref 6.0mm, HCG-M60DModel HCG, Midstream

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number69572903MBZYZP Basic UDI-DIDate16 Feb 2022RegisteredStatusActive
European UnionCE/IVDR Number69572903MBZYZP Basic UDI-DIDate16 Feb 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
One Step HCG Pregnancy Test
Model / Reference
HCG, 6.0mm, Midstream, HCG-M60D
Primary DI / UDI-DI
06957290300140
Basic UDI-DI
69572903MBZYZP, B-06957290300140
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
Class IVD devices for self-testing
Market of Registration
Germany
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000019986
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Reagent NoEUDAMEDYesEUDAMED
  • Self Testing NoEUDAMEDYesEUDAMED

Other properties (9)

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