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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

UNIQA Monofocal Lens, Myopic

UDI-DI 07640167751464Basic UDI-DI 764016775PHAKOLJ5

Class IIb · MDR · Ziemer Ophthalmic Lenses AG

Identification
Model
UNIQA Monofocal Lens; UNIQA Monofocal Toric Lens
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

1000333005

EU technical documentation assessment · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2026-09-08 · Expiry 2031-09-07

Scope not stated in certificate data.

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

1000273869

EU quality management system · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2026-09-08 · Expiry 2031-09-07

Scope not stated in certificate data.

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

Manufacturer

Ziemer Ophthalmic Lenses AG

SRN CH-MF-000049603

CH · Port

manufacturer

Authorised representative: Ziemer Ophthalmology (DE) GmbH (DE-AR-000005638)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/uniqa-monofocal-lens-myopic-1464 · UDI page: /udi/07640167751464

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