ATS Dental Amalgator TAC-400M Mode D'emploi page 20

Manufacturer's name
Manufacturer's Address
Name of Device:
Code:
Device category:
Device class
This declaration is based on the following elements:
Technical File n°
that the Medical Device specified above is in conformity with the Directive 93/42/EEC and subsequent
amendments contained in according with the Directive Rule 89/336/CEE, 92/31/CEE and 98/68/CEE and
that that the following harmonized standards have been applied:
EN 61010-1 - EN61010-2-81-EN61326-1 - EN61000-3-2 – EN6100-3-3 -ISO 7488 :1991
Date: 01/03/2016
Location: Serravalle P.se
DFU - FTC400 Rev. 0 - Mar 2016
Page 20 di 24
EC Declaration of Conformity
(Directive 93/42/EEC – Class I – Annex IX Rule 12)
ATS DENTAL srl
Via Vecchia Provinciale Lucchese, 49/F
51030 SERRAVALLE PISTOIESE (PT) – ITALY
Amalgamator TAC 400/M
TAC 1003 – TAC 1009 – TAC 1012 – TAC 1010/1
Medical Device
CLASS I Annex IX Rule 12
FTC400
Technical File and supporting documentations are retained under the
premises of the Manufacturer and at disposition of the Competent
Authorities
We the undersigned,
certify and declare
Dr. Daniele Poli
President Chief Executive Officer
ATS DENTAL srl – Advanced Technology Solution
Stamp