Declaration of Conformity

2733
(Document No. / Pranešimo Nr.)
(Year, Month (yyyy/mm) in which the CE mark is affixed / Metai, kada CE
patvirtino)
2021/02
EU DECLARATION OF CONFORMITY
(EC ATITIKTIES DEKLARACIJA)
We, PHILIPS CONSUMER LIFESTYLE B.V.
(Company name / Pavadinimas)
Philips Consumer Lifestyle B.V.
TUSSENDIEPEN 4, 9206 AD DRACHTEN, THE NETHERLANDS
(address / adresas)
declare under our responsibility that the product(s):
(Deklaruojame, kad elektronikos gaminys (-iai):)
Philips Avent
(brand name, firmos ženklo pavadinimas )
SCF391, SCF393, SCF392, SCF394, SCF371, SCF373, SCF372, SCF374
(Type version or model, Tipas arba modelis)
Philips Avent Single / Double electric breast pump
(product description, gaminio aprašymas)
to which this declaration relates is in compliance with the following Union harmonisation legislation:
(šiai deklaracijai, sutinkamai su toliau nurodytais jungtiniais harmonizacijos reglamentais:)
Referring to the following harmonised standards:
(Sutinkamai su šiais harmonizuotais standartais:)
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
(Pagaminta atitinkant visus kokybės reikalavimus pagal ISO 9001 ar CENELEC nuolatinius dokumentus)
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
(Informuota įstaiga)
(Name and number/ Pavadinimas ir numeris)
(atlikta)
(description of intervention / intervencijos aprašymas)
and issued the certificate:
86443CE12
(Sertifikatas išleistas)
(certificate number / sertifikato numeris)
(place,date / vieta, data)
08-Mar-21
(signature, name and function / parašas, vardas, pavardė ir pareigos)
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,