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Singclean®

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

Ref IVD48-02-5t

EMDN W0105041104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06936020111751 Basic UDI-DIDate17 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
COVID-19 IgM Test kit (Colloidal Gold Method)
Model / Reference
IVD48-02-5t
Primary DI / UDI-DI
06936020111751
Basic UDI-DI
B-06936020111751
EMDN Code
W0105041104 Coronavirus igm
Device Class
Class IVD General
Market of Registration
Germany

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.

  • Singclean®

    Class B

  • Earlibird®

    Class B

  • Validcheck®

    Class B

  • Pretthyal®

    Class III

  • Pepino®

    Class B

  • Singclean

    Class C

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
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 73741fdf-05f6-44d8-997f-9b6d949e97fe 61 fields · synced 22 Oct 2026