EU Declaration of conformity

2733
(Document No. / Döküman Numarası)
(Year, Month (yyyy/mm) in which the CE mark is affixed / CE İbaresinin
eklendiği yıl (yyyy/aa))
2021/02
EU DECLARATION OF CONFORMITY
(EU UYGUNLUK BEYANI)
PHILIPS CONSUMER LIFESTYLE B.V.
(Company name / İmalatçının ismi)
Philips Consumer Lifestyle B.V.
TUSSENDIEPEN 4, 9206 AD DRACHTEN, THE NETHERLANDS
(address / İmalatçının adresi )
This declaration of conformity is issued under the sole responsibility of
the manufacturer
(Bu uygunluk beyanı yalnızca imalatçının kendi sorumluluğu altında
düzenlenir)
Philips Avent
(brand name, İsim )
SCF391, SCF393, SCF392, SCF394, SCF371, SCF373, SCF372, SCF374
(Type version or model, Tip veya model)
Philips Avent Single / Double electric breast pump
(product description, Ürün Açıklamas )
to which this declaration relates is in compliance with the following Union harmonisation legislation:
((bu beyanın ilgili olduğu) aşağıdaki Union uyumlaştırma mevzuatına uygundur:)
Referring to the following harmonised standards:
(Aşağıdaki uyumlaştırılmış standartlara atıfta bulunmaktadır:)
EN 60601-1:2006/AC:2010/A1:2013, EN 60601-1-2:2015, EN 60601-1-6:2010, EN 60601-1-11:2010
EN 62304:2006/AC:2008
EN 62366:2008
EN ISO 10993-1:2009 /AC:2010, EN ISO 10993-5:2009, EN ISO 10993-10:2013, EN ISO 10993-18:2009
EN ISO 14971:2012
EN ISO 10079-1:2015, EN ISO 15223-1:2016
EN 1041:2008, EN 62133-2:2017
EN 50563:2011+A1:2013
EN 14350:2020
93/42/EC
2011/65/EU
2012/19/EU
2004/1935/EC
2011/10/EU, 2006/2023/EC
And are produced under a quality scheme at least in conformity with ISO 9001 or CENELEC Permanent Documents
(En az ISO 9001 veya CENELEC Daimi Belgelerine uygun kalite şemasına binaen mevcut ürünlerdir)
Only for Medical Devices produced under a quality scheme at least in conformity with EN13485:
The Notified Body:
DEKRA Certification B.V. CE03
performed:
Class IIa rule 11. MDD Annex
(Yetkili Kurul)
(Name and number/ Isin ve numara)
(yerine getirmiştir)
(description of intervention /müdahalenin tanımı )
and issued the certificate:
86443CE12
(sertifikayı düzenlemiştir)
(certificate number / sertifika numarası)
(place,date / Yer ve tarih )
08-Mar-21
(signature, name and function / İmza, isim ve görevi)
Remarks:
SCF391, SCF393, SCF371, SCF373: Philips Avent Single/Double
electric breast pump Plus for single/multiple user. SCF392, SCF394,
SCF372, SCF374: Philips Avent Single/Double electric breast pump
Premium Plus for single/multiple user. I
A.Speelman, CL Compliance Manager
Drachten,