_________________________________________________
_________________________________________________________________
11
TOM Child Bed
August 1999, 1
st
Edition
EC CONFORMITY DECLARATION
Date of issue: 27. 9. 2001
Conformity declaration issued by:
Commercial name
Linet spol. s r. o.
Registered address
Želev
č
ice 5, 274 01 Slaný, Czech Republic
Reg. No.
00507814
Telephone
+420 312 576 111
Fax
+420 312 522 668
As the producer of the product -
name (brand):
TOM 115/140
Variants of the product:
1331XXXXXXXXX (the variants are specified in the
technical documentation of the product)
Description and function
designation:
Positionable children bed for children hospital units
Clssification of the product as the
medical device:
Class I nonsterile, without measuring function
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 MDD
93/42/EEC which stipulates the technical parameters for healthcare products.
C) Means of assessing conformity
Conformity was assessed by the procedure stated MDD 93/42/EEC, Annex VII
.
Ing. Zbyn
ě
k Frolík
company director
