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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

Fundus Image Analysis Software

UDI-DI 06975169730027Basic UDI-DI 697516973002MCS6R

Class IIa · MDR · Visionary Intelligence Ltd.

Identification
Model
MCS
EMDN
V92
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

CN23/00004797

EU quality management system · unknown

Notified body: SGS Belgium NV (1639)

Valid from 2025-02-27 · Expiry 2028-09-07

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Visionary Intelligence Ltd.

SRN CN-MF-000018621

CN · Beijing

manufacturer

Authorised representative: Shanghai International Holding Corp. GmbH(Europe) (DE-AR-000000001)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/fundus-image-analysis-software-0027 · UDI page: /udi/06975169730027

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