Our folding disposable mask (particulate respirator) has Obtained Chinese standard GB2626-2006 and European CE standard EN 149:2001+A1:2009 FFP2 level. Medical mask has been obtained European CE standard EN14683:2019 Class of Type I, Type II and Type IIR.
Our orthodontic and dental pulp products:
Comply with CFDA: China's Regulations on the Supervision and Administration of Medical Devices
ISO 13485:2012 certified
Complies with US medical device regulations FDA 21 CFR 807
EU CE certification
Certified by Envisa
Our medical devices and products are registered worldwide, including in Asia. Eastern Europe, Middle East, Central and South America