Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Horizon Monofocal

UDI-DI 06923411278315Basic UDI-DI 69234112RSAPRX

Class IIb · MDR · Wuxi Vision Pro LTD

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Identification

Model: RS60AP
EMDN: P030102090201
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

C839261

EU technical documentation assessment · valid

Notified body: DNV Product Assurance AS (2460)

Valid from 2026-06-30 · Expiry 2031-06-29

Scope not stated in certificate data.

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

Manufacturer

Wuxi Vision Pro LTD

SRN CN-MF-000025281

CN · Wuxi, Jiangsu

manufacturer

Authorised representative: Wellkang Ltd (XI-AR-000001836)

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Canonical device page: /device/horizon-monofocal-8315 · UDI page: /udi/06923411278315

All devices from Wuxi Vision Pro LTD

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