Eu Mdr Eu Md Class 1 On The Market 🇨🇭 Switzerland

SenopiMed

Senopi Ag · 🇨🇭 Switzerland
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
07649990898018
Basic UDI-DI Code
7649990898SenopiMedYZ
Reference
SenopiMed
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
Senopi Ag

Additional Description

SenopiMed is an active medical device intended for the prevention and alleviation of physical debility and/or cognitive decline in seniors with age-related physical debility (R54) and/or mild cognitive impairment (G31.84) or who are at increased risk thereof by providing physical and cognitive training which is delivered through a VR headset. The training session may be accompanied by a healthcare professional while the senior is in a clinical setting. The device displays the completion of a programme to both the user (senior) and the healthcare professional but does not give any indication of the user’s performance. Therefore, the device output is of no clinical significance and cannot be used for monitoring purposes and/or clinical decision-making.

CND Nomenclature Codes

Code Description
N010299 NEUROLOGIC PHYSIOTHERAPHY DEVICES - OTHER

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