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11. Identification.
11.1 EG-Konformitätserklärung
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
momo tricycle.
- The tricycle as therapy aid.
Art. No.: 37 01 000 (12“)
37 02 000 (16“)
37 03 000 (20“)
37 04 000 (24“)
37 05 000 (26“)
37 06 000 (26“ XL)
accords with the relevant regulations in the following regulations and
guidelines:
• 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
• DIN EN 14764 City and trekking bicycles - Safety requirements and test
procedure
• DIN EN 14765 Children‘s bicycles - Safety requirements and test
procedure
• DIN EN 60601-1 Medical electrical devices Part 1: General determinations
for safety including the main performance characteristics
This declaration of conformity applies only for products with the article
numbers stated above and is valid until 31.12.2019.
Date
27.08.2014
Signature
Name
Torsten Schuchmann
Role
Safety Representative for Medical Products
