Organization name

BATEC MOBILITY

SRN

ES-MF-000000576

Manufacturer status

—

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

• Consult instructions for use

Primary placement in Spain; available across 16 countries total.

Trade name

BATEC SCRAMBLER 2 PLUS HEMI RIGHT

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.

08436557351869

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.

843655735ELECTRIC9G

Reference / catalog number

2540007

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

The HandBike Batec Electric product electrically powers the manual wheelchair, allowing people with disabilities to travel longer distances.

Additional information URL

https://batec-mobility.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.

• Y122410ELECTRIC PROPULSION UNIT

• Class I medical devices in EUDAMED

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