Ec Declaration Of Conformity - SEFAM Breeze Nasal Manual Del Usuario

EC DECLARATION OF CONFORMITY

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For the following equipment:
Product Group: CPAP Mask and spare parts
Product Model: As Appendix
GMDN Code: 35174
The above product series are herewith confirmed to comply with the requirement set out in the Council
Directive on the harmonization of the laws of member States concerning Medical Devices Directive
(93/42/EEC-M5) described in Article 11.3 a) and Annex II.
This declaration is supported by the EC Certificate No. 47576-2009-CE-RGC-A 3.0 issued by notified
body DNV (0434), and TCF No.TCF-03
For the evaluation regarding the products, the following standards were applied:
The following standards are applied for all our products:
EN 980:2008,
EN ISO 14971:2012,
EN ISO 10993-1:2009
EN ISO10993-5:2009,
EN ISO10993-10:2013,
EN 15986:2011
IEC 62366:2015
The following standards are applied to specific products as below:
Standards
BS EN ISO 17510-2:2009
BS EN ISO 5356-1:2015
BS EN 20594-1:1994
Classification and rule of classification of MD: Class IIa (Annex IX, rule 2)
The following representative in Europe is responsible for this declaration:
mdiEuropa
Langenhagener Strasse71, 30855 Langenhagen, Germany
(Representative name & address)
Person responsible for making this declaration:
Manufacturer name; HSINER CO., LTD.
Manufacturer address: No.312, Jhongshan Rd., Shengang Dist., Taichung City 429, Taiwan
General Manager
(Position / title)
Sleep apnoea breathing therapy. Masks and
application accessories
Anaesthetic and respiratory equipment. Conical
connectors. Cones and sockets
Conical fittings with a 6% (Luer) taper for syringes,
needles and certain other medical equipment
(Legal signature )
Product
AUG 08, 2016
(Date)