EU Declaration of conformity

3265
(Document No. / Številka poročila)
(Year, Month (yyyy/mm) in which the CE mark is affixed / Leto namstitve
CE znaka)
2021/02
EU DECLARATION OF CONFORMITY
(Izjava o skladnosti)
We, PHILIPS CONSUMER LIFESTYLE B.V.
(Company name / Ime)
Philips Consumer Lifestyle B.V.
TUSSENDIEPEN 4, 9206 AD DRACHTEN, THE NETHERLANDS
(address / Naslov)
declare under our responsibility that the product(s):
(S polno odgovornostjo izjavljamo)
Philips Avent
(brand name, Ime znamke)
SCF338
(Type version or model, Tip, verzija ali model)
Double Breast pump kit
(product description, Opis proizvoda)
to which this declaration relates is in compliance with the following Union harmonisation legislation:
(na katerega se nanaša ta izjava, je skladen z naslednjo usklajevalno zakonodajo Unije:)
Referring to the following harmonised standards or other technical specifications:
(S sklicevanjem na naslednje usklajene standarde ali druge tehnične specifikacije:)
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
(In so proizvedeni v skladu s shemo kakovosti najmanj v skladu z ISO 9001 ali CENELEC stalnimi dokumenti)
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
(Priglašeno organ)
(Name and number/ Ime in številka)
(Izvršeno)
(description of intervention / Opis ukrepa )
and issued the certificate:
86443CE12
(Izdaja certifikat)
(certificate number / Številka certifikata)
(place,date / Kraj, datum)
07-Jun-23
(signature, name and function / Podpis, Ime in funkcija)
Remarks:
Class IIa rule 4
A.Speelman, CL Compliance Manager
Drachten,