EU Declaration of conformity

EDC EN-SER:
2733
(Document No. / Dokument br.)
(Year, Month (yyyy/mm) in which the CE mark is affixed / Godina kada je
dodeljena CE oznaka)
2021/02
EU DECLARATION OF CONFORMITY
(EU DEKLARACIJA O USAGLAŠENOSTI)
We, PHILIPS CONSUMER LIFESTYLE B.V.
(Company name /Naziv privrednog društva )
Philips Consumer Lifestyle B.V.
TUSSENDIEPEN 4, 9206 AD DRACHTEN, THE NETHERLANDS
(address / adresa)
declare under our responsibility that the product(s):
(izjavljujemo pod punom odgovornošću da je(su) električni proizvod(i):)
Philips Avent
(brand name, naziv robne marke )
SCF391, SCF393, SCF392, SCF394, SCF371, SCF373, SCF372, SCF374
(Type version or model, Verzija tipa ili model)
Philips Avent Single / Double electric breast pump
(product description, opis proizvoda )
to which this declaration relates is in compliance with the following Union harmonisation legislation:
(na koje se ova izjava odnosi usklađeni su sa sledećim propisima za harmonizaciju u Uniji:)
Referring to the following harmonised standards:
(Odnosi se na sledeće harmonizovane standarde:)
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
(I da su proizvedeni prema šemi kvaliteta koja je najmanje u skladu sa ISO 9001 ili CENELEC stalnom dokumentacijom)
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
(Ovlašćeno telo)
(Name and number/ Naziv i broj)
(izvršeno)
(description of intervention / opis intervencije)
and issued the certificate:
86443CE12
(i izdat sertifikat)
(certificate number / broj sertifikata)
(place,date / potpis, ime i funkcija)
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,