Legal information to UNITY OUTCOME

Legal manufacturer information

This information relates to the UNITY OUTCOME app, version 1

Legal Manufacturer 

Manufacturer Address

RAYLYTIC Software GmbH
Gottschedstraße 4
04109 Leipzig, Germany

Support Contact

https://raylytic.atlassian.net/servicedesk/customer/portals

Email: support@raylytic.com
Tel: +49 341 656702-30

Swiss Representative

toedtli-consulting, Neudorfstrasse 56, 8820 Wädenswil, Swiss

Contact name: Jost Tödtli

E-mail: consulting@toedtli.info

Tel.: +41 79245 40 12

UDI

UDI-DI	UDI-PI (current UNITY platform version)	UDI (01)4262473810012(8012)x.y.z
4262473810012	Example: 9.29.0	Example: (01)4262473810012(8012)9.29.0
Please note that the latest UDI-PI (colored blue) is available in the UNITY platform in the footer.

Legal Note

The UNITY OUTCOME app is a medical software device. 

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and / or patient is established. 

Intended use

Device description

Indications

Patient population

User profile

Use environment

Conditions of use

Requirements for use / Anforderungen für die Verwendung

Further information to the clinical eCRF/PROM assessment

https://help.raylytic.com/ukb-en/

Liability

CE-Marking

The UNITY OUTCOME app is a medical device according to the Medical Device Regulation (MDR (2017/745)) and bears the CE - mark. 

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