Certificates

CERTIFCATE ISO 13485:2016 MDSAP (english)
NRTL CERTIFCATE (english)
EU ZERTIFIKAT zum Qualitätssicherungssystem (mit Anlage) (german)
ZERTIFIKAT EN ISO 13485:2016 (german)
EU CERTIFICATE for the Quality Assurance System (with Annex) (english)
CERTIFCATE EN ISO 13485:2016 (english)
MDR Declaration of Conformity Bone Conductor Class IIa Version 02 (multilingual)
MDR Declaration of Conformity Earphones Class I Version 06 (multilingual)
MDR Declaration of Conformity Earphones Class IIa Version 01 (multilingual)
MDR Declaration of Conformity Earprobes Class I Version 07 (multilingual)
MDR Declaration of Conformity Earprobes Class IIa Version 01 (multilingual)
MDR Declaration of Conformity ECC Class I Version 05 (multilingual)
MDR Declaration of Conformity ECC Class IIa Version 01 (multilingual)
MDR Declaration of Conformity Electrode Cable Class I Version 04 (multilingual)
MDR Declaration of Conformity Headphones Class IIa Version 01 (multilingual)
MDR Declaration of Conformity Senti Sentiero Class I Version 04 (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 04 (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)
MDR Declaration of Conformity nanoaudio Class Ia Version 02 (multilingual)
MDR Declaration of Conformity nanoAudio Class IIa Version 02 (multilingual)

FDA 510(k) Premarket Notification