Declaration of Conformity

3265
(Document No.)
(Year, Month (yyyy/mm) in which the CE mark is affixed )
2021/02
EU DECLARATION OF CONFORMITY
We, PHILIPS CONSUMER LIFESTYLE B.V.
(Company name)
Philips Consumer Lifestyle B.V.
TUSSENDIEPEN 4, 9206 AD DRACHTEN, THE NETHERLANDS
(address)
declare under our responsibility that the product(s):
(brand name)
SCF338
(Type version or model)
Double Breast pump kit
(product description)
to which this declaration relates is in compliance with the following Union harmonisation legislation:
Referring to the following harmonised standards or other technical specifications:
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
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
(Name and number)
and issued the certificate:
86443CE12
(certificate number)
(place,date)
07-Jun-23
(signature, name and function)
Remarks:
Class IIa rule 4
A.Speelman, CL Compliance Manager
Drachten,

Summary of content (23 pages)