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One Step hCG Urine Test

by Atlas Link Technology Co., Ltd. EUDAMED

Active European Union

Ref C1104.01Model Cassette

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberIVDR 783876 Date29 Jul 2026IssuedStatusActive expires 14 Oct 2030

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  • Withdrawn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 783876 Supplemented

    Technical documentation EU IVDR

    Notified body
    Notified body 2797
    Issued
    29 Jul 2026
    Expires
    14 Oct 2030
    Reason
    Add device or group

Specification

EUDAMED

Model / Reference
Cassette, C1104.01
Primary DI / UDI-DI
06970725815019
Basic UDI-DI
697072581B1HCG00N25S11CRP
Direct Marketing DI
06970725815019
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.

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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