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8. Identification.
8.1 EC declaration of conformity
Company
Schuchmann GmbH & Co.KG
Dütestr. 3
D-49205 Hasbergen
Tel.: +49 (0) 54 05 / 909 - 0
Fax: +49 (0) 54 05 / 909 - 109
declares on their sole responsibility that the product named below is
classified as product class 1
hts.
The universal hygiene system
Art. No.: 57 0x xxx (Z1xx)
The relevant regulations of the regulations and guidelines listed below
accord with:
• EC Directive 93/42/EEC on medical products from 14th June 1993
• DIN EN 12182 Technical aids for the disabled
• EN ISO 14971 Medical products - Application of risk management
on medical products
• ISO 7176-8 Wheelchairs - Part 8: Requirements and tests on static
strength, impact and fatigue strength
This declaration of conformity applies only for products with the article
numbers stated above and is valid until 31.12.2019.
Date
26.02.2018
Signature
Name
Torsten Schuchmann
Role
Safety Representative for Medical Products
