Statement

Sun Nuclear´s corporate management system meets the stringent requirements of the appropriate worldwide standards, including ISO 13485, ISO 9001, FDA 21 CFR 820 Quality System Regulations, Health Canada’s CMDCAS, and the European Medical Device Directive 93/42. Sun Nuclear is certified or licensed to these standards, and is authorized to affix the CE mark on our products for marketing and distribution in the Member States of the European Union.

Our quality systems registrar and European Notified Body for our Class II and above medical products is BSI, a prominent Notified Body recognized worldwide. Our Class 1 medical products are listed in Europe with the Competent Authority of the Netherlands.

Should the need arise to report any safety or health related issues or concerns regarding the use of Sun Nuclear products, a representative is available for our European customers to contact. Our Authorized European Representative in Europe is:

EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31.70.345.8570
Fax: +31.70.346.7299

Download our ISO 9001 BSI eCertificate

Download our ISO 13485 BSI eCertificate