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Dr. Max Pregnancy Test Comfort

by Guangzhou Decheng Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref 0961MCX001 (10)

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberIVDR 783371 Date19 Feb 2026IssuedStatusWithdrawn cancelled expires 12 Mar 2030 withdrawn 30 Sep 2026

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 783371 Cancelled

    Technical documentation EU IVDR

    Notified body
    Notified body 2797
    Issued
    19 Feb 2026
    Expires
    12 Mar 2030
    Reason
    Other

Specification

EUDAMED

Device Name
Pregnancy Rapid Test
Model / Reference
0961MCX001 (10)
Primary DI / UDI-DI
08595566428822
Basic UDI-DI
697446459096PB
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000013536
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Guangzhou Decheng Biotechnology Co., Ltd.

See all devices from Guangzhou Decheng Biotechnology Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Self Testing

Other properties (8)

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