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Appendix 7 Verklaring van conformiteit
WE:
MANUFACTURER: Focal Meditech B.V.
ADDRESS: Droogdokkeneiland 19
TEL: +31 13 533 3103
FAX: +31 13 533 5004
WEBSITE: www.focalmeditech.nl
HEREBY DECLARE THAT THE DEVICE:
DEVICE (MODEL):
872FOCSAGWG**ABA921
872FOCSAGWG**ABA920
872FOCAGWG**ABB163
872FOCSAGWG**ABB122
872FOCSAGWG**ABB123
872FOCSAGWG**ABB212
872FOCSAGWG**ABB213
872FOCSAGWG**ABB144
872FOCSAGWG**ABB145
872FOCSAGWG**ABB140
872FOCSAGWG**ABB141
872FOCSAGWG**ABB214
872FOCSAGWG**ABB215
872FOCSAGWG**ABB130
872FOCSAGWG**ABB131
872FOCSAGWG**ABB132
872FOCSAGWG**ABB159
872FOCSAGWG**ABB133
872FOCSAGWG**ABB134
872FOCSAGWG**ABB135
872FOCSAGWG**ABB136
872FOCSAGWG**ABB631
872FOCSAGWG**ABB630
872FOCASTM**ABB741
COMPLY WITH THE FOLLOWING STANDARDS:
NUMBER
EN ISO 14971
ISO 10993-1
EN12182
IEC 60601-1
IEC 62079
AND IF APPLICABLE, COMPLY WITH THE FOLLOWING DIRECTIVES:
NUMBER
93/42/EEC
89/336/EEC
73/23/EEC
93/68/EEC
WITH LVFS 2001:6 TRANSPONDING THE EUROPEAN MEDICAL DEVICE DIRECTIVE
93/42/EEC.
SIGNED AT:
DATE:
5026 SP Tilburg Netherlands
DESCRIPTION
Subassembly Gowing
Subassembly Mounting Base
Eneaswitch+ UI board Eneaswitch + Focal bus cable 750
Loadarm with arm swing right (Large)
Loadarm with arm swing left (Large)
Loadarm with arm swing left (X-Large)
Loadarm with arm swing right (X-Large)
Subassembly wrist support Right
Subassembly wrist support (Left)
Subassembly Elbow fitting Left (Large)
Subassembly Elbow fitting Right (Large)
Subassembly Elbow fitting Left (Small)
Subassembly Elbow fitting Right (Small)
Subassembly Armfitting size 1 Right
Subassembly Armfitting size 1 Left
Subassembly Armfitting size 2 Right
Subassembly Armfitting size 2 Left
Subassembly Armfitting size 3 Right
Subassembly Armfitting size 3 Left
Subassembly Armfitting size 4 Right
Subassembly Armfitting size 4 Left
Subassembly Armfitting size 5 Right
Subassembly Armfitting size 5 Left
Smart Tilt Module Gowing
TITLE
Medical devices - Application of risk management to medical
Biological evaluation of medical devices - evaluation and testing
Assistive products for persons with disability - General requirements and test methods
Medical electrical equipment : General requirements for basic safety and essential
performance
Preparation of instructions
TITLE
Medical Device Directive
Electromagnetic Compatibility Directive
Low Voltage Equipment Directive
CE Marking Directive
Tilburg, The Netherlands
1-10-2014
27 van 28
P.C.M. Groenland
Directeur
SIGNATURE:
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