Founded in 2001, Shanghai-based Apolomed designs and manufactures professional medical aesthetic systems, with more than 135,000 square feet dedicated to manufacturing and research and development. Its platforms are used by distributors and clinics in more than 80 countries, while regional service centers in New York and Toronto extend factory-direct training and technical support. Apolomed operates under ISO 13485 and MDSAP quality certifications and holds market-specific clearances and registrations, including U.S. FDA 510(k) authorizations.
ISO 13485
certification
CE Marking through TÜV Rheinland (0197)
certification
MDSAP
certification
D-U-N-S Registered
registration
RoHS
compliance_program
US FDA 510(k) Clearance
certification
Australian Register of Therapeutic Goods (ARTG)
registration
Brazil ANVISA Marketing Authorization
certification