Declaración De Conformidad Ce; Ec Conformity Declaration - Linet Multicare Manual De Usuario

17 Declaración de conformidad CE

EC CONFORMITY DECLARATION

Date of issue: 3. 1. 2011
Conformity declaration issued by:
Commercial name
Registered address
Reg. No.
Telephone
Fax
As the producer of the product - name
(brand):
Variants of the product:
Description and function designation:
Classification of the product as the medical
device:
A) Declaration
I declare that the said product is safe under the conditions of common use in compliance with the instructions
and that measures have been taken to ensure the conformity of all the products brought to market with basic
requirements of directives related thereto, stated in paragraph B.
B) Fulfilled technical requirements
This product's characteristics comply with the technical parameters related to it and stated in directive
93/42/EEC as amended, which stipulates the technical parameters for healthcare products and in directive
90/384/EEC as amended, which stipulates the technical parameters for non automatic weighing instruments.
C) Means of assessing conformity
Conformity was assessed by the procedure stated in the directive 93/42/EEC as amended, Annex
VII in conjunction with Annex V.
D) Used standards
The said product fulfils the requirements of these harmonized technical standards: EN 60601-
1:2006, EN 60601-1-2:2007, EN 60601-1-4:1996, EN 60601-2-52:2010, EN 980:2008, EN
1041:2008 and non harmonized technical standards: EN ISO 14971:2009, which were used for
assessing of conformity.
Ing. Zbyn k Frolík
managing director
Producto: Multicare
Versión: 02
Linet spol. s r. o.
Želevþice 5, 274 01 Slaný, Czech Republic
00507814
+420 312 576 111
+420 312 522 668
Multicare
1MC
(Variants are specified in the technical documentation of the
product).
Electrically operated hospital bed intended for use in the intensive
care.
Class Im nonsterile, with measuring function
1293
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