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One Step LH Urine Test

by Atlas Link Technology Co., Ltd. EUDAMED

Active European Union

Ref C1108Model Midstream Stick

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970725810427 Basic UDI-DIDate13 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
One Step LH Urine Test
Model / Reference
Midstream Stick, C1108
Primary DI / UDI-DI
06970725810427
Basic UDI-DI
B-06970725810427
EMDN Code
W0102160304 Lh - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

Manufacturer details

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

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Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Self Testing
  • Professional Testing

Other properties (5)

  • Sterile: No
  • Human Tissues: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No