Quality and Safety
GymnaUniphy plc is certified in accordance with international quality standard ISO 13485; 2003.
All pieces of equipment comply with the European Medical Directive 93/42/EEC and are thus CE certified.
What does this mean for you?
CE means that for all of our equipment, the European Medical Device Directive 93/42/EEC is perfectly respected, from development to delivery. This also means that GymnaUniphy remains responsible for its equipment during the complete life cycle.
Certification agencies that grant the CE label, divide devices into three categories:
- category I = low complexity
- category II = moderate complexity
- category III = high complexity
You can recognise category I devices by their CE label (for example high/low treatment couches).
Category II and III devices have a CE label followed by a number of 4 figures (category II, for example, contains almost all physiotherapy equipment, while category III, for example, includes pacemakers).