Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

Opthaem

UDI-DI 08057502450057Basic UDI-DI 805750245OPTHGN

Class IIb · MDR · Project Engineering srl

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Identification

Model: On Demand / Endless
EMDN: Z1203020202
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: Yes
Reusable surgical: No

Certificates

MDR 00154-A

EU quality management system · valid

Notified body: KIWA CERMET ITALIA S.P.A. (0476)

Valid from 2026-06-05 · Expiry 2031-06-04

Scope not stated in certificate data.

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

Manufacturer

Project Engineering srl

SRN IT-MF-000009571

IT · Impruneta

manufacturer

Related UDI-DIs

Opthaem 08057502450064

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/opthaem-0057 · UDI page: /udi/08057502450057

All devices from Project Engineering srl

Scan an inventory CSV