Ancar SD300 - Page 3

ISO 9001 ISO 13485
109037-AQ-IBE 112630-AQ-IBE
EC Declaration of Conformity (Directive 93/42/EEC)
Manufacturer’s Name
ANTONI CARLES, S.A.
With manufacturing and putting together of medical devices license number 2509-PS granted by
the Health Authorities of Spain.
Name of device: Type or Model:
Dental Unit
GMDNS Code: 34991
Sd-300 Scandinavian
Device Class according to the intended use and the criteria of Annex IX of the Directive:
Class IIa (rule 11)
Scope of Application: All (including parts and accessories)
Power Supply: 220-240 V ~ / 50-60 Hz
Electric Classification: Type BF
This Declaration is based on Certificates issued by DNV:
#78388-2010-CE-IBE-NA according to annex V, DIR 93/42/EEC.
#109037-2012-AQ-IBE-ENAC according to ISO 9001:2008.
#112630-2012-AQ-IBE-NA according to ISO 13485:2003.
Notified Body:
0434 DNV (Det Norske Veritas) – Region Norge As.
We, the undersigned, under our sole responsibility, certify and declare that the medical devices specified
above are in conformity with the essential requirements, which are applicable to them, of RD 1591/09,
transposition to the Spanish law of the directive 93/42/EC as amended by the directive 2007/47/EC. We also
declare that we comply with the design and construction requirements of the following standards:
EN 1640 :2009
Dentistry. Medical devices for dentistry. Equipment.
EN ISO 7494-1:2011
Dentistry. Dental Units. Part 1. General requirements and test methods.
EN ISO 7494-2:2003
Dentistry. Dental Units. Part 2. Water and air supply.
EN 60601-1:2006
+ AC :2010
Medical Electrical Equipment. General requirement for safety.
EN 60601-1-2:2007
+ AC :2010
Medical Electrical Equipment. General requirement for safety.
Electromagnetic Compatibility – Requirements and tests.
EN ISO 14971 :2012
Medical Devices. Application of Risk Management to Medical Devices.
Authorized Signatory Stamp, Date
Josep Álvarez Antoni Carles Bosch December 3, 2013
Regulatory & Safety Officer General Manager
Antoni Carles, S.A.
Volta dels Garrofers, 41-42
Pol. Ind. Els Garrofers
08340-Vilassar de Mar
(Barcelona-SPAIN)
T. (34) 93 754 07 97
F. (34) 93 759 26 04
calidad@ancar-online.com
www.ancar-dental.com
ANTONI CARLES, S.A.
Pol. Ind. “Els Garrofers
C/Volta dels Garrofers, 41-42.
08340 VILASSAR DE MAR
BARCELONA-SPAIN