Quality Standards
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
Australia
Costa-Rica
Mexico
Bolivia
India
Ecuador
Vietnam
Download Standards
CE - MDR
ISO - 13845
FDA 510(k)
EC Declaration of conformity- class IIB
EC Declaration of conformity- class I
Free Sale Certificate - class IIB
Free Sale Certificate - class I