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

PowerScope

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.

00190746067587

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.

01907460000175E6

Reference / catalog number

852-030576

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

FIXED FUNCT POWERSCOPE CLOSED CHANNEL ATTACHMENT NUTS 5 RIGHT AND 5 LEFT

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.

• Q010499ORTHODONTIC DEVICES - OTHER

• Class IIa medical devices in EUDAMED

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