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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

Invisalign Palatal Expander

UDI-DI 00816063021391Basic UDI-DI 081606302IPESystem6S

Class IIa · MDR · Align Technology Inc.

Identification
Model
Invisalign Palatal Expander System
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

3831212CE01

EU quality management system · unknown

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

Valid from 2026-07-02 · Expiry 2029-10-28

Scope not stated in certificate data.

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

Manufacturer

Align Technology Inc.

SRN US-MF-000000744

US · San Jose

manufacturer

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

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/invisalign-palatal-expander-1391 · UDI page: /udi/00816063021391

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