Certifications

All our products are subject to stringent regulatory and quality requirements. This enables us to guarantee high-quality products which meet the medical device regulatory requirements for safety and performance.

All our medical devices are CE-marked. Our products comply with the safety and performance requirements of the European Directive on medical devices (93/42/EEC) and the quality system requirements of the ISO 13485.

Furthermore, we have regulatory product approvals in a wide variety of countries including the US, Australia and Canada.

 EN ISO 13485-2016

2130424 CAN-CSA ISO 13485

96395CE01 CE sterile wound care products

96395CE02 CE Cryotherapy

96395CE03 CE Instant Cooling Device