Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Packed Panel PC ASSY, 5D iTero Element, RMA

UDI-DI 00816063021704Basic UDI-DI 081606302DISBH

Class IIa · MDR · Align Technology Ltd.

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Identification

Model: iTero Element 5D Family
EMDN: Z110601
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

3903048CE01

EU quality management system · valid

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

Valid from 2024-06-18 · Expiry 2029-06-01

Scope not stated in certificate data.

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

Manufacturer

Align Technology Ltd.

SRN IL-MF-000000745

IL · Petach Tikva

manufacturer

Authorised representative: Align Technology B.V. (NL-AR-000000061)

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iTero Element 5D DOA Kit 00816063022053
iTero Element 5D Laptop Configuration 00816063022565
iTero Element 5D Laptop Configuration 00816063020509
iTero Element 5D Laptop Configuration 00816063020936
iTero Element 5D Laptop Configuration Upgrade Kit 00816063020578
iTero Element 5D Plus 00816063022541
iTero Element 5D Plus 00816063020691
iTero Element 5D Plus mobile configuration 00816063022596
iTero Element 5D Plus Mobile Configuration 00816063020745

Showing 12 of 19 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/packed-panel-pc-assy-5d-itero-element-rma-1704 · UDI page: /udi/00816063021704

All devices from Align Technology Ltd.

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