Organization name

BY CONNIEHANSEN 2015 ApS

SRN

DK-MF-000043166

Manufacturer status

Active

Primary placement in Austria; available across 32 countries total.

Trade name

STORM RUNNER

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.

57440047003011

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.

5744004700301WH

Reference / catalog number

01

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

STORM RUNNER, is built to individual measurements in BTR 110 chrome steel over a basic design in sizes 4½ & 5½. That is, they are MDR as "Equipment after individual meassurements".

Additional information URL

https://by-conniehansen.com/manuals/

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.

• Y120606WHEELED WALKER

• Class I medical devices in EUDAMED

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