No Certificate Found

Snapshot 2026-10-11 · Link to EUDAMED

iTero Element Scanner Sleeve

UDI-DI 00816063022183Basic UDI-DI 081606302SLEEVE6S

Class IIa · MDR · Align Technology Ltd.

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Identification

Model: iTero Element Scanner Sleeves
EMDN: Z12119085
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-11 · 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 Scanner Sleeve 00816063020585

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/itero-element-scanner-sleeve-2183 · UDI page: /udi/00816063022183

All devices from Align Technology Ltd.

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