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Singclean

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

Ref IVD49-02-10tModel Cassette

EMDN W0105099099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69360201188X 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 823886 Issued

    Technical documentation EU IVDR

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

Specification

EUDAMED · synced 24 Oct 2026

Device Name
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Method)
Model / Reference
Cassette, IVD49-02-10t
Primary DI / UDI-DI
06936020141543
Basic UDI-DI
69360201188X
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class C
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 06936020141543|69360201188X 61 fields · synced 24 Oct 2026