Eg-Conformity Declaration - Swisspowertube POWERTUBE FPT.B1 Gebrauchsanweisung

16. EG-Conformity declaration

CE 0482
Name and address of the
company
We declare in the position as solely responsible company that
the medical electrical equip-
ments
of class
meets the provisions of the directive 93/42/EEC and its transpositions in national laws
which apply to it. The declaration is valid in connection with the "final inspection
report" of the device.
Conformity assessment
procedure
Validity of Conformity
Notified Body
CH-Forst, April 15, 2021
52
English
Swisspowertube AG
Breite 9
CH-3636 Forst
Switzerland
POWERTUBE (gold)
Typ FPT.B1
POWERTUBE (silver)
Typ FPT-D.B2
IIa rule 9
according to Annex IX of Directive 93/42/EEC
Directive 93/42/EEC
without section 4
January 22, 2024
MEDCERT GmbH
Pilatuspool 2
D-20355 Hamburg
0482
Martin Frischknecht, CEO
English
53