Certificates

Quality management

• EN ISO 13485:2016 incl. AC:2018 + A11:2021  (PDF)

FDA registration (US)

Owner-Operator Number: 10043226

• Establishment Number: 3007515069 (Gewerbestraße)
• Establishment Number: 3013111980 (Neureutstraße)

MHLW registration (Japan)

• certificates 2024 till 2029 (PDF)