Organization name

INTCO MEDICAL (HK) CO., ltd

SRN

CN-MF-000011338

Manufacturer status

Active

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

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

• CW011

  Wheelchairs are prohibited for vertebral fractures, orthodontic surgery, unconsciousness and visual impairment.

Primary placement in Türkiye; available across 32 countries total.

Trade name

Electric Wheelchair

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.

04897128666067

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.

489712866-0-MWheelchairX2

Reference / catalog number

R258

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

Wheelchair is an equipment for disabled aids and mobility aids, the role is the compensation for wound or disability.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 18 MU28

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

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

• Y122106REAR SELF-PROPELLED WHEELCHAIRS

• Class I medical devices in EUDAMED