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English
English
16. EG-Conformity declaration
CE 0482
Name and address of the
company
Famedtec GmbH
Breiten 9, CH-3636 Forst
We declare in the position as solely responsible company that
the medical electrical equip-
ments
POWERTUBE (gold)
Typ FPT.B1
POWERTUBE (silver)
Typ FPT-D.B2
in safety class
IIa
according to Appendix IX of the Directives
93/43/EWG
all required standards of the directives mentioned in the medical dispositions 93/42/
CEE are herewith completely fulfilled and adhered to.
Conformity evaluation
procedure
Medical dispositions 93/42/CEE,
Appendix II
Responsible evaluation centre
for the issuance of this confor-
mity declaration
MEDCERT GmbH
Pilatuspool 2
D-20355 Hamburg
CE
0482
This conformity declaration is valid only together with the corresponding clearance
documents for the production of theses devices.
CH-Forst BE 2020
Werner Frischknecht
(CEO of Famedtec GmbH)
Valid time of the certificate
2023-01-23
