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One Step LH Urine Test

by Atlas Link Technology Co., Ltd. EUDAMED

Active European Union

Ref C1108.02Model C1106.01

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberIVDR 783878 Date3 Jul 2026IssuedStatusActive expires 26 Apr 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 783878 Active Supplemented

    Technical documentation EU IVDR

    Notified body
    2797
    Issued
    3 Jul 2026
    Expires
    26 Apr 2031
    Reason
    Add device or group

Specification

EUDAMED

Model / Reference
C1106.01, C1108.02
Primary DI / UDI-DI
06970725814302
Basic UDI-DI
697072581B1LTH00N30S11CEG
EMDN Code
W0102160304 Lh - 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

Other properties (10)

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