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14423-INS-LAB-RevE13 35
Manufactured for GF Health Products, Inc., 2935 Northeast Parkway,
Atlanta, GA 30360
Product Ultrasound Pocket Doppler
Classication (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
Notied Body TÜV SÜD Product Service GmbH, Ridlerstr 65,
D-80339 München, Germany.
Identication
number