4262480390019

Organization name

Smoke Free 23 GmbH

SRN

DE-MF-000014018

Manufacturer status

Active

Primary placement in Germany; available across 1 country total.

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

Trade name

not provided

UDI-DI code

04262480390019

Basic UDI-DI

426248039SFSC

Reference / catalog number

4262480390019

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Smoke Free is not intended for diagnosis, treatment or medical decision-making, but serves as a patient-centred support tool for disease management. As a DiGA, Smoke Free supports the treatment of tobacco dependence as defined by the ICD-10-GM code F17.2 (‘Mental and behavioural disorders due to tobacco, dependence syndrome’). The application is theory-led and evidence-based. It follows the German S3 guideline on tobacco cessation as well as the recommendations from Great Britain, the USA and the World Health Organisation on tobacco cessation.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

This device is not currently linked to any other device.