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

 

PDF DocumentCE-MARKING-Sterilewoundcareproducts-0344.pdf

PDF DocumentCE-MARKING-Cryotherapy-0344.pdf

PDF DocumentCE-MARKING-Instantcoolingdevice-0344.pdf

PDF DocumentCAN-CSA ISO 134852-2003.pdf

PDF DocumentEN ISO 13485-2012.pdf 

 

 

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