Loading…
Manufacturer of cardio-pulmonary diagnostic systems based in Aue, Germany since 1998.
GermanyFounded 1998Healthcare ManufacturerDIN EN ISO 13485:2021-12Medical Device Directive 93/42/EEC
certificate other
Notified Body confirmation letter from SLG Prüf- und Zertifizierungs GmbH regarding the status of MDR application and written agreement for AMEDTEC Medizintechnik Aue GmbH under Regulation (EU) 2023/607.
certificate other
Notified Body confirmation letter regarding the status of a formal application, written agreement, and surveillance under Regulation (EU) 2023/607 for AMEDTEC Medizintechnik Aue GmbH, confirming transitional provisions for medical devices.
