Global Medical Device Certifications
All Aersmedica products have passed authoritative certifications at home and abroad, fully comply with global medical device sales and procurement standards.
Our Certifications
FDA 510K
US FDA 510(K) clearance for medical devices. Authorizes legal commercial distribution in the United States.
CE MDR
European Medical Device Regulation certification. Mandatory for all medical devices sold within the EU market.
ISO13485
International standard for quality management systems specific to medical device design and production.
RoHS
Restriction of Hazardous Substances compliance, ensuring products are free from harmful materials.
Biocompatibility Test
Independent laboratory biocompatibility testing confirming product safety for human contact use.