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Singclean®

by Hangzhou Singclean Medical Products Co., Ltd. China EUDAMED

Ref LH-03-20tModel Strip, Cassette, Midstream

EMDN W0102160304

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69360201218L Basic UDI-DIDate17 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 823882 Issued

    Technical documentation EU IVDR

    Notified body
    Notified body 2797
    Issued
    17 Aug 2026
    Expires
    16 Aug 2031

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Luteinizing Hormone (LH) Ovulation Test Kit (Colloidal Gold)
Model / Reference
Strip, Cassette, Midstream, LH-03-20t
Primary DI / UDI-DI
06936020109581
Basic UDI-DI
69360201218L
EMDN Code
W0102160304 Lh - rt & poc
Device Class
Class B
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000014098
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Hangzhou Singclean Medical Products Co., Ltd.

See all devices from Hangzhou Singclean Medical Products Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Self Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 9c20aca4-661f-4bd0-9b48-8f8e2870eb42 61 fields · synced 23 Oct 2026