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Cervical Cytology Image Processing System

by Winmedic Tech Co., Ltd.

Ref WinCyto

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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 Number697743004WinCyto52 Basic UDI-DI 06977430041023UDI-DIDate15 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Cervical Cytology Image Processing System
Model / Reference
WinCyto
Primary DI / UDI-DI
06977430041023
Basic UDI-DI
697743004WinCyto52
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
Special Device Type
Software
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000041945
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Winmedic Tech Co., Ltd.

See all devices from Winmedic Tech Co., Ltd. →

Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No