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We look forward to your inquiry, be it to learn more about QUMEA, to let you experience QUMEA in a live demo, or to arrange a reference visit to one of our customers.
And if you ever feel like having a coffee in the most beautiful baroque city of Switzerland, we would be happy to welcome you in our beautiful offices in the heart of the city of Solothurn for a real Italian espresso.
Inquiry
QUMEA AG
Westbahnhofstrasse 3
CH-4500 Solothurn
Switzerland
QUMEA AB
QUMEA AB
Melodislingan 50
SE-115 51 Stockholm
Sweden
QUMEA AG
QUMEA AG
Franz-Volhard-Straße 5
D-68167 Mannheim
Germany
QUMEA AG
Franz-Volhard-Straße 5
D-68167 Mannheim
Germany
Regulatory Statement & Conformity
MDR Statement
QUMEA Care is not a medical device according to Regulation (EU) 2017/745 and therefore does not fall within its scope of the same.
QUMEA Care is intended for the prevention of injuries. According to Article 2 paragraph 1 of Regulation (EU) 2017/745 (European Union Medical Device Regulation - MDR), the prevention of an injury is not a medical purpose. The movement and activity data as recorded and displayed by QUMEA Care are ultimately intended to be used to prevent injuries. The device is not intended to be used for "diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury" and accordingly, not for a specific medical purpose.
QUMEA Mobility Sense is a Class 1 medical device according to Regulations (EU) 2017/745 (European Union Medical Device Regulation - MDR) and MepV (2020/812.213).
QUMEA Mobility Sense is intended to be used for prevention of Decubitus ulcers and pressure areas (ICD L89). The product is solely used to inform the caretaker when a patient did not show a certain level of mobilization for a specific amount of time. The required level of mobilization is defined as a change in posture of the recumbent subject (e.g. turning from supine to lateral position). No diagnostic or therapeutic decisions can be made based on the output of the data.
Conformity (CE)
QUMEA sensor products are in conformity with European health, safety, and environmental protection standards.
QUMEA AG CHRN: CHRN-MF-20002870
Classification and conformity documentation, as well as additional documents, are available upon request from QUMEA AG.
Disclosure
Responsible for the content:
QUMEA AG
Westbahnhofstrasse 3
CH-4500 Solothurn
+41 (0)32 525 60 50
info@qumea.com
UID: CHE-439.197.016
Legal form: Public Limited Company
Contact Person:
Cyrill Gyger
Please also see QUMEA's Privacy Policy.
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Images used under license from kandis-fotografie.ch, QUMEA AG, Shutterstock.com.
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