Declaration of Conformity

2733
(Document No. / Nr. raport)
(Year, Month (yyyy/mm) in which the CE mark is affixed / Anul în care
este aplicat marcajul CE)
2021/02
EU DECLARATION OF CONFORMITY
(DECLARAŢIE DE CONFORMITATE CE)
We, PHILIPS CONSUMER LIFESTYLE B.V.
(Company name / Nume)
Philips Consumer Lifestyle B.V.
TUSSENDIEPEN 4, 9206 AD DRACHTEN, THE NETHERLANDS
(address / adresă)
declare under our responsibility that the product(s):
(Declarăm pe proprie răspundere că produsul (produsele) electric(e))
Philips Avent
(brand name, marca)
SCF391, SCF393, SCF392, SCF394, SCF371, SCF373, SCF372, SCF374
(Type version or model, Tip sau model)
Philips Avent Single / Double electric breast pump
(product description, descriere produs)
to which this declaration relates is in compliance with the following Union harmonisation legislation:
(la care se referă prezenta declarație este în conformitate cu următoarea legislație de armonizare a Uniunii:)
Referring to the following harmonised standards:
(Se referă la următoarele standarde armonizate:)
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
(Şi sunt fabricate după o schemă de calitate conformă cel puţin cu standardul ISO 9001 sau Documentele Permanente CENELEC)
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
(Organismul notificat)
(Name and number/ Nume si număr)
(a efectuat)
(description of intervention / descrierea intervenţiei)
and issued the certificate:
86443CE12
(Şi a emis certificatul)
(certificate number / Numărul certificatului)
(place,date / locul, data)
08-Mar-21
(signature, name and function / semnătura, nume şi funcţie)
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,