Skip to content

One Step hCG Urine Test

by Atlas Link Technology Co., Ltd. 9 variants

Ref C1105.03Model Cassette

Active European Union

CE IVDR

Valid until

14 Oct 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands 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 NumberIVDR 783876 Date29 Jul 2026IssuedStatusActive expires 14 Oct 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 783876 Active Supplemented

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    29 Jul 2026
    Expires
    14 Oct 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  • Withdrawn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
Cassette, C1105.03
Primary DI / UDI-DI
06970725814982
Basic UDI-DI
697072581B1HCG00N25S11CRP
Direct Marketing DI
06970725814982
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000021058
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Atlas Link Technology Co., Ltd.

See all devices from Atlas Link Technology Co., Ltd. →

Properties

  • Self Testing
  • Near-Patient Testing

Other properties (9)

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