No Certificate Found

Snapshot 2026-10-09 · Link to EUDAMED

iTero Element Flex

UDI-DI 00816063022527Basic UDI-DI 081606302ELEMENT6L

Class I · MDR · Align Technology Ltd.

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Identification

Model: iTero Element 2 family
EMDN: Z110601
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-09 · Link to EUDAMED

Manufacturer

Align Technology Ltd.

SRN IL-MF-000000745

IL · Petach Tikva

manufacturer

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

Related UDI-DIs

iTero Element 2 00816063020288
iTero Element 2 00816063022480
iTero Element 2 00816063020912
iTero Element 2 DOA 00816063022046
iTero Element 2 Plus 00816063020684
iTero Element 2 Plus 00816063022534
iTero Element 2 Plus 00816063020851
iTero Element 2 Plus DOA Service Kit 00816063021070
iTero Element 2 Plus, mobile configuration 00816063022503
iTero Element 2 Plus Mobile configuration 00816063020738
iTero Element Flex 00816063020295
iTero Element Flex 00816063020905

Showing 12 of 15 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/itero-element-flex-2527 · UDI page: /udi/00816063022527

All devices from Align Technology Ltd.

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