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Appendix 1 Verklaring van conformiteit
WE:
MANUFACTURER:
ADDRESS:
TEL:
FAX:
WEBSITE:
hereby declare under our sole responsibility that the CE-marked
products to which this declaration relates,
DEVICE (MODEL):
872FOCSABLC**ABC091
872FOCSABLC**ABD291
(**) means each number between 00 and 99 (for internal use Focal)
have been classified as Class I, according to Annex IX, rule
number 1,
and are in conformity with the essential requirements and provisions of the
Council Directive 93/42/EEC concerning medical devices as amended by
Directive 2007/47/EC
and are subject to the procedure set out in Annex VII of the Council Directive
93/42/EEC as amended by Directive 2007/47/EC.
SIGNED AT:
Tilburg, The Netherlands
DATE:
28-8-2017
DECLARATION OF
CONFORMITY
Focal Meditech B.V.
Droogdokkeneiland 19
5026 SP Tilburg
Netherlands
+31 13 533 3103
+31 13 533 5004
www.focalmeditech.nl
DESCRIPTION
Balancer complete
Balancer complete (Heavy duty)
SIGNATURE:
P.C.M. Groenland
CEO
12 van 14
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