Legal manufacturer information
Legal manufacturer:  RAYLYTIC Software GmbH | Customer Support Contact: | |
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Product information according to MDR (EU 2017/745), Annex VI UNITY OUTCOME is a medical device intended for structured outcomes assessment. It forms part of the modular UNITY platform. The UNITY platform itself is not a medical device, but is considered an accessory to UNITY OUTCOME in the sense of MDR Article 2(2). Versioning is based on the UNITY platform releases. Each release has a unique version number (e.g., 9.28.0) which unambiguously identifies the included version of UNITY OUTCOME. A traceable mapping between UNITY platform releases and the software version of UNITY OUTCOME is ensured and documented in the technical file. | ||
UDI-DI: 4262473810012 UDI-PI: 9.28.0 |  (01)4262473810012(8012)9.28.0 | |
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Please note, the most current UDI-PI (red colored) is available in UNITY platform in the bottom line. | ||
 The UNITY OUTCOME App, Version 1 is a medical device |  UNITY OUTCOME is a medical device in accordance with the Medical Device Regulation (MDR (2017/745)) and bears the CE mark | Any serious incident that has occurred in connection with UNITY OUTCOME should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient resides. |
Legal representative for Switzerland:  Jost Tödtli | Contact: toedtli-consulting E-mail: consulting@toedtli.info | |
Liability A suitable infrastructure with internet access must be guaranteed in order to use UNITY OUTCOME. The availability and reliability of the infrastructure may restrict the use of the UNITY OUTCOME application. | ||
