Organization name

American Orthodontics

SRN

US-MF-000007702

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• MR UNSAFE

  MR Unsafe

• EUH 203 – Contains chromium (VI). May produce an allergic reaction.

  Contains chromium

Primary placement in Netherlands; available across 31 countries total.

Trade name

Empower Bracket

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00190746189708

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

01907460000124DM

Reference / catalog number

126-029951

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

1 PAT SETUP SL EMPOWER DUAL ACT ROTH 022 U/L 5X5 W/HK 3,4,5 STICKY BX

Additional information URL

https://www.americanortho.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Q010403ORTHODONTIC BRACKETS AND BUTTONS

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

No certificate specifically references this device's Basic UDI-DI.