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Fully Automated Digital Slide Scanning System

by Suzhou Ruiqian Technologies Co., Ltd. 3 variants

Ref SC‑WSI‑001Model WSI-2100;WSI-2200;WSI-2400

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697654345WSI2UB Basic UDI-DI 06976543450012UDI-DIDate10 Sep 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  • Withdrawn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

Model / Reference
WSI-2100, WSI-2200, WSI-2400, SC‑WSI‑001
Primary DI / UDI-DI
06976543450012
Basic UDI-DI
697654345WSI2UB
Direct Marketing DI
06976543450012
EMDN Code
W0202050304 Digital laboratory microscopes
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000058310
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Suzhou Ruiqian Technologies Co., Ltd.

Properties

  • Human Tissues
  • Professional Testing
  • Surgical Instrument
  • New Device

Other properties (7)

  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No