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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Hydrophilic Acrylic Foldable IOL - Clear

UDI-DI 00840570400004Basic UDI-DI 08405704HA-IOL-CLEARZ6

Class IIb · MDR · Eyekon Medical Inc.

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

1000289397

EU technical documentation assessment · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2026-07-14 · Expiry 2031-07-13

Scope not stated in certificate data.

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

1000171284

EU quality management system · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2026-07-14 · Expiry 2031-07-13

Scope not stated in certificate data.

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

Manufacturer

Eyekon Medical Inc.

SRN US-MF-000046490

US · Clearwater

manufacturer

Authorised representative: MedEnvoy Global BV (NL-AR-000024028)

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/hydrophilic-acrylic-foldable-iol-clear-0004 · UDI page: /udi/00840570400004

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