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Rapid Vitamin D Self-Test

by Zhejiang Orient Gene Biotech Co., Ltd EUDAMED

Active European Union

Ref GIVD-402b-DRH10HGModel GIVD-402b-H1, GIVD-402b-H2, GIVD-402b-H5, GIVD-402b-H10, GIVD-402b-H20

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69509960GIVD-402bEW Basic UDI-DIDate9 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 6188440TD12 Issued

    Technical documentation EU IVDR

    Notified body
    Notified body 0344
    Issued
    1 Sep 2026
    Expires
    1 Sep 2031
  • 6188440CE01 Supplemented

    Quality management system EU IVDR

    Notified body
    Notified body 0344
    Issued
    1 Sep 2026
    Expires
    1 Apr 2030
    Reason
    Add device or group

Specification

EUDAMED

Model / Reference
GIVD-402b-H1, GIVD-402b-H2, GIVD-402b-H5, GIVD-402b-H10, GIVD-402b-H20, GIVD-402b-DRH10HG
Primary DI / UDI-DI
06950996078726
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017965
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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