Graham Field GRAFCO 14423-8 - Manual (Page 35)

14423-INS-LAB-RevD11 35
10 APPENDIX A, EC DECLARATION OF
CONFORMITY
EC Declaration of Conformity
Manufactured for GF Health Products, Inc., 2935 Northeast Parkway,
Atlanta, GA 30360
Product Ultrasound Pocket Doppler
Classification (MDD, Annex IX): IIa
We herewith declare that the above mentioned product(s) meet the
transposition into national law, the provisions of Council Directive
93/42/EEC of 14 June 1993 concerning medical devices - as amended by
Directive 98/79/EC on in vitro diagnostic medical devices.
All supporting documentation is retained at the premises of the
manufacturer.
Directives
General Applicable Directives: Medical Device
Directive: COUNCIL DIRECTIVE 93/42/EEC of 14
June 1993 concerning medical devices (MDD 93/42/
EEC).
Standards applied EN ISO 9001, ISO13485, EN ISO14971, EN ISO10993-
1, IEC 601-1, EN 60601-1-1, BS EN 60601-1-4, IEC
60601-1-2, EN 61157, EN 1041, EN 60417-2-2000,
IEC/TR 60878-2003, EN 980, EN 55011, ISO 1000, YY
0111-93, EN 61266, EN ISO 780 , GB/T 14740, GB/T
15464
Notified Body TÜV SÜD Product Service GmbH, Ridlerstr 65, D-
80339 MÜnchen, Germany.
Identification
number