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Appendix 7 Declaration of Conformity
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):
872FOCSADWG**ABB817
872FOCSADWG**ABB819
872FOCSADWG**ABB885
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
COMPLY MET THE FOLLOWING STANDARDS:
NUMBER
EN ISO 14971
ISO 10993-1
EN12182
IEC 62079
AND IF APPLICABLE, COMPLY MET THE FOLLOWING DIRECTIVES:
NUMBER
93/42/EEC
89/336/EEC
93/68/EEC
MET LVFS 2001:6 TRANSPONDING THE EUROPEAN MEDICAL DEVICE DIRECTIVE 93/42/EEC.
SIGNED AT:
DATE:
5026 SP Tilburg Netherlands
DESCRIPTION
Subassembly Dowing
Subassembly Table clamp
Subassembly Chair clamp
Load arm with arm swing Right (Left)
Load arm with arm swing Left (Left)
Load arm with arm swing Left (X-Left)
Load arm with arm swing Right (X-Left)
Subassembly wrist support Right
Subassembly wrist support (Left)
Subassembly Elbow fitting Left (Left)
Subassembly Elbow fitting Right (Left)
Subassembly Elbow fitting Left (Small)
Subassembly Elbow fitting Right (Small)
Subassembly Arm fitting size 1 Right
Subassembly Arm fitting size 1 Links
Subassembly Arm fitting size 2 Right
Subassembly Arm fitting size 2 Links
Subassembly Arm fitting size 3 Right
Subassembly Arm fitting size 3 Links
Subassembly Arm fitting size 4 Right
Subassembly Arm fitting size 4 Links
Subassembly Arm fitting size 5 Right
Subassembly Arm fitting size 5 Links
TITLE
Medical devices - Application of risk management to medical
Biological evaluation of medical devices - evaluation and testing
Assistive products for persons met disability - General requirements and test methods
Preparation of instructions
TITLE
Medical Device Directive
Electromagnetic Compatibility Directive
CE Marking Directive
Tilburg, The Netherlands
1-10-2015
SIGNATURE:
20 of 21
P.C.M. Groenland
Directeur
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