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Rapid Iron Deficiency Ferritin Test

by Zhejiang Orient Gene Biotech Co., Ltd 20 variants

Ref GEFER-402a-H2Model GEFER-402a-H1, GEFER-402a-H2, GEFER-402a-H5, GEFER-402a-H10, GEFER-402a-H20

Active European Union

CE IVDR

Valid until

1 Apr 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69509960GEFER-402aSW Basic UDI-DI 06950996091404UDI-DIDate9 Oct 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 6188440TD13 Active

    Technical documentation EU IVDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 Sep 2026
    Expires
    1 Sep 2031
  • 6188440CE01 Active Supplemented

    Quality management system EU IVDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 Sep 2026
    Expires
    1 Apr 2030
    Reason
    Add device or group

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
GEFER-402a-H1, GEFER-402a-H2, GEFER-402a-H5, GEFER-402a-H10, GEFER-402a-H20
Primary DI / UDI-DI
06950996091404
Basic UDI-DI
69509960GEFER-402aSW
EMDN Code
W0102070102 Ferritin
Device Class
Class C
EU 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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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