Certificates
- EN ISO 13485:2016 | pdf | 137 kb
- EN ISO 13485:2016 (MDSAP) | pdf | 129 kb
- EC Certificate - Annex II | pdf | 835 kb (extended until 2027-12-31 and 2028-12-31, respectively)
- Extension Letter EC Certificate | pdf | 175 kb
- MDR Quality Management | pdf | 183 kb