Declaration of Conformity

2733
(Document No. / Rapportnummer)
(Year, Month (yyyy/mm) in which the CE mark is affixed / Årstal for
påhæftning af CE-mærkningen)
2021/02
EU DECLARATION OF CONFORMITY
(EU KONFORMITETSERKLÆRING)
We, PHILIPS CONSUMER LIFESTYLE B.V.
(Company name / Virksomhedens navn)
Philips Consumer Lifestyle B.V.
TUSSENDIEPEN 4, 9206 AD DRACHTEN, THE NETHERLANDS
(address / adresse)
declare under our responsibility that the product(s):
(Erklærer i henhold til vores ansvar, at de(t) elektriske produkt(er))
Philips Avent
(brand name, navn på varemærke)
SCF391, SCF393, SCF392, SCF394, SCF371, SCF373, SCF372, SCF374
(Type version or model, type eller model)
Philips Avent Single / Double electric breast pump
(product description, produktbeskrivelse)
to which this declaration relates is in compliance with the following Union harmonisation legislation:
(til hvilke(t) denne erklæring relaterer sig, er i overensstemmelse med følgende EUharmoniseringslovgivning:)
Referring to the following harmonised standards:
(Med reference til følgende harmoniserede standarder:)
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
(Og er produceret i en kvalitet, der, som minimum, opfylder kravene i ISO 9001-standarden eller CENELEC's permanente dokumenter)
Only for Medical Devices produced under a quality scheme at least in conformity with EN13485:
The Notified Body:
DEKRA Certification B.V. CE0
performed:
Class IIa rule 11. MDD Annex
(Det Notificerede Organ)
(Name and number/ Navn og nummer)
(har gennemført)
(description of intervention / beskrivelse af intervention)
and issued the certificate:
86443CE12
(og udstedt erklæringen)
(certificate number / erklæringsnummer)
(place,date / sted, dato)
08-Mar-21
(signature, name and function / Signatur, navn og titel)
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,