Manufacturer's Name:
Physitrack Ltd.
Registered Trademark:
Physitrack
Manufacturer's Address:
6th Floor, 125 Wood St
London. EC2V 7AN
United Kingdom
London. EC2V 7AN
United Kingdom
Name of Device:
Physitrack Software Platform
Classification:
Class: I (according to Medical Devices Directive (93/42/EEC)
Conformity Assessment Route:
Physitrack Ltd. applied the procedures for the CE-labelling of the product in accordance with the Council Directive 93/42 (EEC) and Medical Devices Regulation (EU) 2017/745
GMDN Code:
Self-care monitoring/reporting software - 58884
We hereby declare that the medical device (Software) specified above meets the provisions of the Council Directive No. 93/42/EEC for Medical Devices and issued under the sole responsibility of Physitrack Ltd.
The Software as medical device covered by the present EU declaration is in conformity with the (EU) MDR 2017/745.
All supporting documentation for this EC Declaration of Conformity is retained in the document management system of the manufacturer.
Breht McConville
Chief Compliance Officer
Physitrack Limited