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Singclean®

by Hangzhou Singclean Medical Products Co., Ltd. 4 variants

Ref IVD49-02-1t

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936020115094 Basic UDI-DI Date17 Dec 2025RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
COVID-19 Test kit (Colloidal Gold Method)
Model / Reference
IVD49-02-1t
Primary DI / UDI-DI
06936020115094, 06936020115223, 06936020111690
Basic UDI-DI
B-06936020115094, B-06936020115223, B-06936020111690
EMDN Code
W0105041101 Coronavirus ag
Device Class
Class IVD devices for self-testing
Class IVD General
EU 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.

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

Properties

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

Other properties (5)

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