Certificates

CERTIFCATE ISO 13485:2016 MDSAP (english)
EG ZERTIFIKAT zum Qualitätssicherungssystem (mit Anlage) (german)
ZERTIFIKAT EN ISO 13485:2016 (german)
EC CERTIFICATE for the Quality Assurance System (with Annex) (english)
CERTIFCATE EN ISO 13485:2016 (english)
MDR Declaration of Conformity Bone Conductor Class IIa Version 01 (multilingual)
MDR Declaration of Conformity Earphones Class I Version 03 (multilingual)
MDR Declaration of Conformity Earphones Class IIa Version 01 (multilingual)
MDR Declaration of Conformity Earprobes Class I Version 05 (multilingual)
MDR Declaration of Conformity Earprobes Class IIa Version 01 (multilingual)
MDR Declaration of Conformity ECC Class I Version 03 (multilingual)
MDR Declaration of Conformity ECC Class IIa Version 01 (multilingual)
MDR Declaration of Conformity Electrode Cable Class I Version 03 (multilingual)
MDR Declaration of Conformity Headphones Class IIa Version 01 (multilingual)
MDR Declaration of Conformity Senti Sentiero Class I Version 03 (multilingual)
MDR Declaration of Conformity Senti Sentiero Class IIa Version 01 (multilingual)
Declaration of Conformity PATH Class I Version 03 (Australia)
Declaration of Conformity PATH Class IIa Version 06 (Australia)
MDR Declaration of Conformity Tymp-MU Class IIa Version 01 (multilingual)
MDR Declaration of Conformity ALGO 7i Class I Version 03 (multilingual)
MDR Declaration of Conformity ALGO 7i Class IIa Version 01 (multilingual)
Declaration of Conformity ALGO 7i Class I Version I (Australia)
Declaration of Conformity ALGO 7i Class IIa Version 04 (Australia)
MDR Declaration of Conformity QScreen Class IIa Version 01 (multilingual)

FDA 510(k) Premarket Notification