Quality Certificates
Our products are made with strict quality checks and meet the highest global standards, ensuring top-quality for you and your patients
MDR EU
FDA 510(k)
ISO 13485:2026
Australia
Costa-Rica
Mexico
Bolivia
India
Ecuador
Vietnam
Download Certificates
CE - MDR
Regulation (EU) 2017/745
Regulation (EU) 2017/745
ISO 13485:2026
FDA 510(k)
EC Declaration of conformity- class IIB
EC Declaration of conformity- class I
Free Sale Certificate - class IIB + class 1