Our folding disposable facepiece (particulate respirator) has obtained China standard GB2626-2006, European CE standard EN 149:2001+A1:2009 FFP2 level. The medical face mask have obtained European CE standard EN14683: 2019 Type I, Type II and Type IIR level.
Our orthodontic and endodontic products:
Compliance with CFDA: Regulations for the Supervision and Administration of Medical Devices in China
Certified according to ISO 13485:2012
Compliance with USA Regulations for Medical Devices FDA 21 CFR 807
CE Certification for the European Union
Certified according to Envisa
Worldwide registration of our medical devices and products including in Asia. East Europe, Middle East, Central & South America