EU Declaration of conformity

2733
(Document No.)
(Year, Month (yyyy/mm) in which the CE mark is affixed )
2021/02
EU DECLARATION OF CONFORMITY
We, PHILIPS CONSUMER LIFESTYLE B.V.
(Company name)
Philips Consumer Lifestyle B.V.
TUSSENDIEPEN 4, 9206 AD DRACHTEN, THE NETHERLANDS
(address)
declare under our responsibility that the product(s):
Philips Avent
(brand name)
SCF391, SCF393, SCF392, SCF394, SCF371, SCF373, SCF372, SCF374
(Type version or model)
Philips Avent Single / Double electric breast pump
(product description)
to which this declaration relates is in compliance with the following Union harmonisation legislation:
Referring to the following harmonised standards:
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
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 V/VII
(Name and number)
and issued the certificate:
86443CE12
(certificate number)
(place,date)
08-Mar-21
(signature, name and function)
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,