CE Declaration of Conformity

Manufacturer's Name:
Physitrack PLC
Registered Trademark:
Physitrack
Manufacturer's Address:
Bastion House, 6th Floor
140 London Wall
London EC2Y 5DN
United Kingdom
Name of Device:
Physitrack Software Platform
Classification:
Class: I (according to Medical Devices Directive (93/42/EEC)
Conformity Assessment Route:
Physitrack PLC 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 PLC.

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 PLC