Technical Information; Manufacturer; Declaration Of Conformity - I-Tech T-ONE REHAB Notice D'utilisation

Manufacturer

IACER S.r.l. is an Italian manufacturer of medical devices (certified CE no.
0068/QCO-DM/234-2020 from the Notified Body n° 0068 MTIC InterCert
S.r.l.).

Declaration of conformity

Via S.Pertini 24/A – 30030 Martellago (Ve), Italia
herewith declares under its own responsibility, that the family of products
which includes the following models
has been designed and manufactured according to the European Medical
Device Directive 93/4/EEC (transposed in Italy by the D.Lgs. 46/97), as
modified by the Directive 2007/47/EC (D.Lgs.37/2010) and further
modifications/integrations.
The products have been assigned to class IIa, according to Annex IX, rule 9 of
the Directive 93/42/EEC (and further modifications/integrations) and bear the
mark
Compliance of the concerned products with the Directive 93/42/EEC has been
assessed and certified by the notified body:
Via G. Leopardi 14, Milano (MI) 20123, Italia
following the certification procedure according to Annex II (excluding point 4)
of the Directive 93/42/EEC.
Martellago, 03/08/2020
________________
Place, date
IACER Srl
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. 041.5401356 • Fax 041.5402684
I.A.C.E.R. S.r.l
Rehab, Medi Pro, Medi Sport and Coach
UMDNS Code: 13762
0068 – MTIC InterCert S.r.l.
Certified number: 0068/QCO-DM/234-2020
T-ONE
_____________________
Legal Representative
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Technical information

MASSIMO MARCON
MNPG236-02