Certificates & declarations of conformity
ISO 13485:2016 MDSAP certificate (English)PDF
NRTL CERTIFCATE (English)PDF
EC quality assurance system certificate with annex (German)PDF
EN ISO 13485:2016 certificate (German)PDF
EC quality assurance system certificate with annex (English)PDF
EN ISO 13485:2016 certificate (English)PDF
MDR declaration of conformity: Bone conductor, Class IIa, version 02 (multilingual)PDF
MDR declaration of conformity: Earphones, Class I, version 06 (multilingual)PDF
MDR declaration of conformity: Earphones, Class IIa, version 03 (multilingual)PDF
MDR declaration of conformity: Earprobes, Class I, version 07 (multilingual)PDF
MDR declaration of conformity: Earprobes, Class IIa, version 02 (multilingual)PDF
MDR declaration of conformity: ECC, Class I, version 06 (multilingual)PDF
MDR declaration of conformity: ECC, Class IIa, version 02 (multilingual)PDF
MDR declaration of conformity: Electrode cable, Class I, version 05 (multilingual)PDF
MDR declaration of conformity: Headphones, Class IIa, version 02 (multilingual)PDF
MDR declaration of conformity: SENTI/SENTIERO, Class I, version 04 (multilingual)PDF
MDR declaration of conformity: SENTI/SENTIERO, Class IIa, version 02 (multilingual)PDF
Declaration of conformity: PATH, Class I, version 03 (Australia)PDF
Declaration of conformity: PATH, Class IIa, version 06 (Australia)PDF
MDR declaration of conformity: TY-MU, Class IIa, version 02 (multilingual)PDF
MDR declaration of conformity: ALGO 7i, Class I, version 04 (multilingual)PDF
MDR declaration of conformity: ALGO 7i, Class IIa, version 02 (multilingual)PDF
Declaration of conformity: ALGO 7i, Class I, version I (Australia)PDF
Declaration of conformity: ALGO 7i, Class IIa, version 04 (Australia)PDF
MDR declaration of conformity: QSCREEN, Class IIa, version 02 (multilingual)PDF
MDR declaration of conformity: nanoaudio, Class I, version 02 (multilingual)PDF
MDR declaration of conformity: nanoaudio, Class IIa, version 02 (multilingual)PDF