Declaration of Conformity

2733
(Document No. / Broj izvještaja)
(Year, Month (yyyy/mm) in which the CE mark is affixed / Godina
ishođenja CE oznake)
2021/02
EU DECLARATION OF CONFORMITY
(Izjava o sukladnosti)
We, PHILIPS CONSUMER LIFESTYLE B.V.
(Company name / Ime)
Philips Consumer Lifestyle B.V.
TUSSENDIEPEN 4, 9206 AD DRACHTEN, THE NETHERLANDS
(address / Adresa)
declare under our responsibility that the product(s):
(Odgovorno izjavljujemo da je elektični uređaj(i))
Philips Avent
(brand name, Naziv robne marke)
SCF391, SCF393, SCF392, SCF394, SCF371, SCF373, SCF372, SCF374
(Type version or model, Tipska oznaka 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 koji se odnosi ova deklaracija u skladu je sa sljedećim zakonima o harmonizaciji Unije:)
Referring to the following harmonised standards:
(Odnosi se na sljedeće norme za harmonizaciju:)
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
(najmanje u skladu sa normom ISO 9001 ili)
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
(Nadležno tijelo)
(Name and number/ Ime i broj)
(Izveden)
(description of intervention / Opis intervencije)
and issued the certificate:
86443CE12
(I izdana je potvrda)
(certificate number / Broj potvrde)
(place,date / Mjesto ,datum)
08-Mar-21
(signature, name and function / Potpis,ime i radno mjesto)
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,