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Singclean®

by Hangzhou Singclean Medical Products Co., Ltd. 65 variants

Ref IVD49-02-50tModel Cassette

Active European Union

CE IVDR CE IVDD

Valid until

16 Aug 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberIVDR 823886 Date17 Aug 2026IssuedStatusActive expires 16 Aug 2031
European UnionCE/IVDD NumberB-06936020116428 Basic UDI-DI Date17 Dec 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 823886 Active

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    17 Aug 2026
    Expires
    16 Aug 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Device Name
COVID-19 Test kit (Colloidal Gold Method)
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Method)
Model / Reference
IVD49-02-50t, Cassette
Primary DI / UDI-DI
06936020116428, 06936020111713, 06936020141581
Basic UDI-DI
B-06936020116428, B-06936020111713, 69360201188X
EMDN Code
W0105041101, W0105099099
Device Class
Class IVD General
Class C
EU market of registration
Germany
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000014098
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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

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

Properties

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

Other properties (6)

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