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7. Identification
7.1 EC declaration of conformity
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 from product class 1
named below fulfils
"MALTE"
- the compact and versatile posterior walker
Art. No.: 35 00 100 (Size 0 Mini) 75 01 000 (Size 1)
75 02 000 (Size 2)
75 03 000 (Size 3)
75 04 000 (Size 4)
"MALTE Outdoor"
- the compact and versatile posterior walker for outdoor use
Art. No.: 75 01 100 (Size 1)
75 02 100 (Size 2)
75 03 100 (Size 3)
the relevant regulations of the guidelines and standards listed below:
•
EC Directive 93/42/EEC on medical products from 14th June 1993
•
DIN EN 12182:1999
Technical aids for the disabled
•
EN ISO 14971
Medical products - Application of risk management
on medical products
•
DIN EN ISO 11199-3:2005 Walking aids manipulated by both arms - Require-
ments and test methods - Part 3: Walking frames
This declaration of conformity applies only for products with the article
numbers stated above and is valid until 01.10.2016.
Date
27.08.2014
Signature ________________________
Name
Torsten Schuchmann
Role
Safety Representative for Medical Products
