Product Manual

4077-INS-LAB-RevB09 41
12 APPENDIX A, EC DECLARATION OF CONFORMITY
EC Declaration of Conformity
Manufactured for GF Health Products, Inc., 2935 Northeast Parkway, Atlanta, GA 30360
Product External Fetal Monitor
Model 4077
Classification (MDD, Annex IX): IIb
We herewith declare that the above mentioned product(s) meet the transposition into national law, the provi-
sions 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 Harmonized Standards (published in the Official Journal of the European Communi-
ties) applicable to this product are: EN ISO 9001, EN 46001, EN 1441, EN 980, IEC
878, EN 30993, EN 540, EN 60601-1, EN 60601-1-2, EN 60601-1-4, EN 475, EN 61157,
ISO 1000, EN 1041.
Notified Body TÜV SÜD Product Service GmbH, Ridlerstr 65, D-80339 München, Germany.
Identification number