EUDAMED device

Invisalign Impression Tray, Plastic, Upper, X-Large

EUDAMED device 00816063020356 · Align Technology Inc.

Key facts

Primary DI 00816063020356
Trade name Invisalign Impression Tray, Plastic, Upper, X-Large
Device name Invisalign Impression Tray
Reference or catalog number 2563
Model Invisalign Impression Tray
Manufacturer Align Technology Inc.
Manufacturer SRN US-MF-000000744
Risk class Class I
EMDN code Q010503
EMDN description IMPRESSION MATERIAL TRAYS, SINGLE-USE
Legislation mdr
Implantable No
Sterile No
Single use Yes
Status date Oct 5, 2023

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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