Esogetics synapsis wave 2 - 9 Applied Standards and Guidelines

9. Applied Standards and Guidelines
Electrical Safety: “Elektrische Sicherheit” DIN EN
60601-1:2013
Electromagnetic Compatibility: “Elektromagnetische Verträg-
lichkeit” DIN EN 60601-1-2:2016
Medical Device Directive:
“Medizinproduktrichtlinie” 93/42/EWG MDD
Classification according to the Medical Device Directive Class,
Appendix 9, Rule 9, Paragraph 1: Class IIa:
Manufacturer:
Esogetics GmbH, Hildastr. 8, D-76646 Bruchsal,
Germany
Telephone: +49 (0) 7251/800 10, Fax: +49 (0) 7251/800 155
Web: www.esogetics.com
Mail: info-de@esogetics.com
Download of the instruction manuals under:
www.esogetics.com/downlowds
Esogetics is a registered medical device manufacturer. We
adhere to a certified and monitored quality management sys-
tem according to Medical Device Directive 93/42/EWG and to
DIN EN ISO 13485 with an implemented monitoring and repor-
ting system.
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