EUDAMED device

Invisalign System - Teen Package

EUDAMED device 00816063021636 · Align Technology Inc.

Key facts

Primary DI 00816063021636
Trade name Invisalign System - Teen Package
Device name Invisalign System
Reference or catalog number 9037
Model Invisalign System
Manufacturer Align Technology Inc.
Manufacturer SRN US-MF-000000744
Risk class Class IIa
EMDN code Q010499
EMDN description ORTHODONTIC DEVICES - OTHER
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Nov 22, 2024

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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