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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 iso
ISO 13485:2016 quality management system certificate issued to AMEDTEC Medizintechnik Aue GmbH for the development, manufacturing, production, service, and distribution of cardiovascular diagnostic devices and software.
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 iso
ISO 13485:2016 quality management system certificate issued to AMEDTEC Medizintechnik Aue GmbH for the development, manufacturing, service, and distribution of cardiovascular diagnostic devices and software.
certificate ce
EC Certificate for Full Quality Assurance System according to Directive 93/42/EEC Annex II, covering cardiovascular diagnostic equipment and software.
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.