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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Invisalign Specifix Attachment System with Engagement Features:

UDI-DI 00816063023784Basic UDI-DI 081606302Specifix8W

Class IIa · MDR · Align Technology Inc.

Identification
Model
—
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-specifix-attachment-system-with-engagement-featur-3784 · UDI page: /udi/00816063023784

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