QT 2025 – 003

Organization name

Hjärtshopen AB

SRN

SE-MF-000048486

Manufacturer status

Active

Primary placement in Sweden; available across 1 country total.

Placed on the market in Sweden; per-country availability dates not published.

Trade name

not provided

UDI-DI code

07350178580013

Basic UDI-DI

7350178582025003EN

Reference / catalog number

QT 2025 – 003

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

2

Additional product description

The Qviktrak system is used to attach the legs to the traction equipment itself. It allows to maintain traction on the injured leg and fix it together with the traction equipment, QvikTrak. The Qviktrak system is also used on the uninjured leg to create an even draft and increase stability in the leg. The system consist of three (3) parts: a) Madrass – a stand-alone component, works together with the Stag b) Stag – Quiktrack, not a stand-alone component, needs to be used with Fotsele c) Fotsele – Quiktrack, not a stand-alone component The fotsele attach the legs/foots to the stag for traction.

Additional information URL

https://qviktrak.com/dokument/

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.

• M03050299BANDAGES AND SPLINTS - OTHER