EU Declaration of conformity

3265
(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)
SCF338
(Type version or model, Tipska oznaka ili model)
Double Breast pump kit
(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 or other technical specifications:
(Odnosi se na sljedeće norme za harmonizaciju ili druge tehničke podatke:)
EN 62366:2008 + A1:2015
EN 62366-1:2015 + A1:2020
EN ISO 14971:2019 + A11:2021
EN ISO 15223-1:2016
EN 1041:2008 + A1:2013
EN ISO 10993-1:2020
EN ISO 10993-5:2009
EN ISO 10993-10:2013
EN ISO 10993-18:2009
93/42/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 Cert. BV CE0344
performed:
MDD Annex V/VII
(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)
07-Jun-23
(signature, name and function / Potpis,ime i radno mjesto)
Remarks:
Class IIa rule 4
A.Speelman, CL Compliance Manager
Drachten,