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Nitrile gloves Control | powdered

Nitrile gloves Control | powdered

Product catalog summary
EU Declaration of Conformity Overview
This document is an EU Declaration of Conformity for a Class I medical device, specifically Nitri le gloves Control, powdered, under the brand Hygostar. The manufacturer, Franz Mensch GmbH, located in Buchloe, Germany, declares that the product complies with the EU directive 93/42/EEC, annex VII.
Product Specifications
  • Item REF: 2600
  • Description: Nitri le gloves Control | powdered
  • Brand: Hygostar
  • Color: Blue
  • Size: XL / 10
  • Length: 24cm
Compliance and Standards
The product meets the provisions of the conformity assessment procedure of the EU directive 93/42/EEC (annex VII) and complies with the following harmonized standards:
  • EN 455-1:2020
  • EN 455-2:2015+A1:2011
  • EN 455-3:2015
  • EN 455-4:2009
Certification and Quality Management
The declaration is signed by Amanda Kreuzmann, Head of Quality Management, on behalf of Franz Mensch GmbH. The company is ISO certified under DIN EN ISO 9001:2015.
Contact Information
Franz Mensch GmbH
Werner-von-Siemens-Str. 2
86807 Buchloe, Germany
Phone: +49 8241 9633-0
Fax: +49 8241 9633-100
Website: www.franz-mensch.de
Email: [email protected]
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Catalog excerpts

Nitrile gloves Control | powdered-1

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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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.