Organization name

Rehasense Sp. z o.o.

SRN

PL-MF-000004772

Manufacturer status

Active

Primary placement in Poland; available across 32 countries total.

Trade name

ICON 130

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.

05907467847405

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.

59074678WHE6J

Reference / catalog number

RW13045GC1

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 / ICON 130 / 45CM SIZE, SH: 50CM , SW:45CM / SOBER GREY COLOR, ALU / 7" AND 16" DRUM BRAKE,ADJUSTED,FOR RSDE.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Drum Brake wheels
• 45 MU10

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

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

• Y122103PUSH WHEELCHAIRS

• Class I medical devices in EUDAMED

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