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Fundus Image Analysis Software

by Visionary Intelligence Ltd.

Model DSS, MCS

Active European Union

CE MDR

Valid until

7 Sep 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

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/MDR NumberCN23/00004797 Date27 Feb 2025IssuedStatusActive expires 7 Sep 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN23/00004797 Active Amended

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    27 Feb 2025
    Expires
    7 Sep 2028
    Reason
    Mnf data change

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
DSS, MCS
Primary DI / UDI-DI
06975169730010, 06975169730027
Basic UDI-DI
697516973001DSS6M, 697516973002MCS6R
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000018621
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Visionary Intelligence Ltd.

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No