Facts & Figures

Facilities:

Binzen (Baden-Württemberg), Germany

Manufacturing Area:

800 m²

Certificates & Registrations:

• SO 13485 Medical devices - Quality Management System
• MDD
  Full quality system according to Directive 93/42/EEC on Medical Devices
• ANVISA
  Brazilian Health Surveillance Agency
• FDA registered
• Australian (TGA) recognition
• Japanese accreditation of foreign medical device manufacturer