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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