EU Declaration of Conformity for a medical device class I (according to the EU directive 93/42/EEC, annex VII) The manufacturer: Franz Mensch GmbH Werner-von-Siemens-Str. 2 D - 86807 Buchloe declares under sole responsibility, that the class I medical device Item REF Description Brand Version 2600 Nitrile gloves Control | powdered Hygostar Color: Blue Size: XL / 10 Length: 24cm complies and meets all the provisions of the conformity assessment procedure of the EU directive 93/42/EEC (annex VII). in accordance with confirmed records, test results or certificates, complies/comply with the requirements of the relevant harmonization legislation: EN EN EN EN The achieved performance levels of this medical device correspond to: Signed for and on behalf of Franz Mensch GmbH, Amanda Kreuzmann Head of Quality Management F ranz Mensch GmbH Werner-von-Siemens-Str. 2 86807 Buchloe, Germany phone: +49 8241 9633-0 fax: +49 8241 9633-100 internet: www.franz-mensch.de e-mail: [email protected] Franz Mensch is a ISO certified company DIN EN ISO 9001:2015
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