Organization name

ID-LOGICAL INDUSTRIA E COMERCIO LTDA

SRN

BR-MF-000034402

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Contains nickel and chromium which may cause allergic reactions in sensitive individuals. Refer to the instructions for use for additional information.

Primary placement in Austria; available across 32 countries total.

Trade name

U1R ID-ONE ROTH .022

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.

07908610032318

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.

B-07908610032318

Reference / catalog number

41121-52101

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Orthodontic appliance used for dental alignment.

Additional information URL

https://www.id-logical.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

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