EUDAMED device

Rollo Band

EUDAMED device 00190746036347 · American Orthodontics

Key facts

Primary DI 00190746036347
Trade name Rollo Band
Device name Rollo Band
Reference or catalog number 141200-0R-2400
Manufacturer American Orthodontics
Manufacturer SRN US-MF-000007702
Risk class Class IIa
EMDN code Q010402
EMDN description ORTHODONTIC BANDS
Legislation mdr
Implantable No
Sterile No
Single use Yes
Status date Jul 31, 2025

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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