Organization name

INTCO MEDICAL (HK) CO., ltd

SRN

CN-MF-000011338

Manufacturer status

Active

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

• CW011

  Do not use the rollator if you have other physical limitations that may cause unsafe use of your rollator, like a weak arm, balance disorders, impaired vision, limb loss

Primary placement in Austria; available across 32 countries total.

Trade name

Rollator

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.

04895272902024

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-RollatorE4

Reference / catalog number

7802

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

This rollator is suitable for a single user with limited mobility. It is suitable for indoor and outdoor use. The purpose of walking devices is to compensate for or at least improve restricted walking ability in users.

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Y120609WALKING FRAMES WITH CHAIR, 4 WHEELS

• Class I medical devices in EUDAMED

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