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TECNIS EYHANCE IOL WITH TECNIS SIMPLICITY DELIVERY SYSTEM

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Snapshot 2026-11-02 · Link to EUDAMED

UDI-DI 05050474655447Basic UDI-DI 5050474a000239C

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Class IIb · MDR · Johnson & Johnson Surgical Vision, Inc.

Identification

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

Certificates

2252965TD02

EU technical documentation assessment · restricted

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

Valid from 2025-07-16 · Expiry 2028-10-01

Scope not stated in certificate data.

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

2252965CE02

EU quality management system · unknown

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

Valid from 2025-07-16 · Expiry 2027-03-01

Scope not stated in certificate data.

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

Manufacturer

Johnson & Johnson Surgical Vision, Inc.

SRN US-MF-000038968

US · Irvine

manufacturer

Authorised representative: AMO Ireland (IE-AR-000013513)

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Showing 12 of 58 other UDI-DIs.

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Canonical device page: /device/tecnis-eyhance-iol-with-tecnis-simplicity-delivery-system-5447 · UDI page: /udi/05050474655447

All devices from Johnson & Johnson Surgical Vision, Inc.