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Asskea proVisio M28 Gebrauchsanweisung Seite 44

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Copyright © 2022 ASSKEA GmbH, Gebesee.
The safety of the ASSKEA proVisio
of technology and meets the requirements of the German Medical Devices Act.
The ASSKEA proVisio
®
with the EU Council Directive 93/42/EEC concerning medical devices and meets the essential
requirements of Annex I of this directive and Article 120 of Regulation (EU) 2017/745 of the
European Parliament and of the Council.
The ASSKEA proVisio
®
The quality management system applied by ASSKEA GmbH is certified in compliance with the
relevant international standards.
The ASSKEA proVisio
®
with EU Council Directive 93/42/EEC, Annex IX.
Errors and omissions excepted.
Page 44 of 84
®
M28 secretion aspirator complies with the recognized rules
M28 secretion aspirator bears the CE marking CE0494 in accordance
M28 secretion aspirator has been tested in accordance with IEC 62353.
M28 secretion aspirator is a class IIa medical aspirator in accordance

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