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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-22 · Link to EUDAMED

PC 545Y QuadrimaX Aspheric

UDI-DI 08717819156065Basic UDI-DI 8717819Quadrimax545/7Q

Class IIb · MDR · Ophtec BV

Identification
Model
5450*TY
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2254207TD01

EU technical documentation assessment · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2025-06-12 · Expiry 2027-11-01

Scope not stated in certificate data.

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

Manufacturer

Ophtec BV

SRN NL-MF-000000048

NL · Groningen

manufacturer

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Canonical device page: /device/pc-545y-quadrimax-aspheric-6065 · UDI page: /udi/08717819156065

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