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EC Declaration of Conformity
3
Medical Device License
Europe
EC DECLARATION OF CONFORMITY
according to the Council Directive 93/42/EEC concerning medical devices
Manufacturer
IBP Medical GmbH
Ikarusallee 15
30179 Hannover
declare under our sole responsibility that the
following products:
Dialysis Reference Meter
Version HDM97BL
HDM97BM
HDM97BN
HDM97BO
HDM97BP
HDM97BQ
HDM99XP
Product Code: 31.0XXX.XX
X = Depending on Version
meet the provisions of the Council Directive
93/42/EEC concerning medical devices
which apply to them.
Product Classification
II B
Notified Body
Medcert GmbH
Vorsetzen 35
20459 Hamburg
Identification Number
0482
Hannover 18.04.09
USA
FDA Registration No. K020908
CANADA
Health Canada Registration No. 34773
Responsible:
Dipl. Ing. Werner Pfingstmann