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)
CERTIFICADO CE para el sistema de aseguramiento (con archivo adjunto) (spanish)
CERTIFICADO EN ISO 13485:2016 (spanish)
Anwendung Art. 97 Abs. 1 i. V. m. Art. 94 Verordnung (EU) 2017/745 über Medizinprodukte
Application Article 97(1) in conjunction with Article 94 or Regulation (EU) 2017/745 on medical devices
Aplicación del artículo 97, apartado 1, leído en relación con el artículo 94 del Reglamento (UE) 2017/745 sobre productos sanitarios
Declaration of Conformity Bone Conductor Class IIa Version 03 (german / english)
MDR Declaration of Conformity Earphones Class I Version 01 (multilingual)
Declaration of Conformity Earphones Class IIa Version 03 (german / english)
MDR Declaration of Conformity Earprobes Class I Version 01 (multilingual)
Declaration of Conformity Earprobes Class IIa Version 10 (german / english)
MDR Declaration of Conformity ECC Class I Version 01 (multilingual)
Declaration of Conformity ECC Class IIa Version 02 (german / english)
MDR Declaration of Conformity Electrode Cable Class I Version 01 (multilingual)
Declaration of Conformity Headphones Class IIa Version 05 (german / english)
MDR Declaration of Conformity Senti Sentiero Class I Version 01 (multilingual)
Declaration of Conformity Senti Sentiero Class IIa Version 14 (german / english)
Declaration of Conformity Senti Sentiero Class I for Australia Version 02 (english)
Declaration of Conformity Senti Sentiero Class II for Australia Version 04 (english)
Declaration of Conformity Tymp-MA Class IIa Version 02 (german / english)
Declaration of Conformity Tymp-MU Class IIa Version 02 (german / english)
MDR Declaration of Conformity ALGO 7i Class I Version 01 (multilingual)
Declaration of Conformity ALGO 7i Class IIa Version 03 (german / english)
Declaration of Conformity ALGO 7i Class IIa for Australia Version 02 (english)
Declaration of Conformity QScreen Class IIa Version 02 (german / english)