Organization name

CoMoveIT

SRN

BE-MF-000017867

Manufacturer status

Active

Primary placement in Belgium; available across 32 countries total.

Trade name

CoMoveIT Smart dF

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.

05430002911045

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.

5430002911CMSMART1DX

Reference / catalog number

CM0001

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

CoMoveIT Smart is a head-and-foot control system for an electric wheelchair designed for people with complex movement disorders. These individuals have little or no ability to control an electric wheelchair using a joystick or any other conventional method. CoMoveIT Smart detects the pressure applied by a user to the system’s head cushions or foot pedals and converts this into control signals for the wheelchair. The system adjusts the level of pressure required from the user in real time to suit the individual. The system consists of a central control unit, a headset and, where applicable, foot pedals with or without a sensor (dF).

Additional information URL

https://comoveit.com/index.php/en/support

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.

• Y122403WHEELCHAIR FOOTRESTS, SUPPORTS AND CONTROLS

• Class I medical devices in EUDAMED

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