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Manufacturer of cardio-pulmonary diagnostic systems based in Aue, Germany since 1998.
AllemagneFondée en 1998Fabricant · SantéDIN 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.
