EU Declaration of conformity

2938
(Document No.)
(Year, Month (yyyy/mm) in which the CE mark is affixed )
2022/03
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):
Philips
(brand name)
SCH400
(Type version or model)
Baby care set
(product description)
to which this declaration relates is in compliance with the following Union harmonisation legislation:
Referring to the following harmonised standards:
EN 60601-1:2006 + A1:2013
EN 60601-1-2:2015, EN 60601-1-6:2010, EN 62366:2008, EN 60601-1-11:2015
ISO 80601-2-56:2009
EN ISO 14971:2012
EN 12470-3:2000 + A1:2009
EN ISO 10993-1:2009 +AC2010, EN ISO 10993-5:2009, EN ISO 10993-10:2010
EN 62304:2006 + AMD1:2015
EN ISO 13485:2016
EN 1041:2008, EN 15223-1:2016
EN 50581:2012
93/42/EEC
2011/65/EU
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 0344
performed:
MDD
(Name and number)
and issued the certificate:
86443CE09
(certificate number)
(place,date)
29-Mar-22
(signature, name and function)
Remarks:
The thermometer is a Class IIa medical device in Europe, according
to Rule 10, Annex V and VII of the MDD – Active devices for
diagnosis
A.Speelman, CL Compliance Manager
Drachten,