148
EU Declaration of Conformity
We Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development District, 528437
Zhongshan, Guangdong, PEOPLE'S REPUBLIC OF CHINA
declare under our sole responsibility that the product
Product Name:
:
Blood Pressure Monitor
Model name:
:
TMB-1585-BT
Software:
V01
Accessories:
Adapter(Model:)KH0601000EW; battery
:
4*AAA
comply with the following directives and regulations:
2014/53/EU (The Radio Equipment Directive)
For the evaluation of the compliance with these Directives and Regulations, the following
standards/requirements were applied:
The conformity assessment procedure as referenced in Article 17 and detailed in Annex III of the
Radio equipment Directive has been followed with the involvement of a notified body:
Notified Body: TUV SUD BABT
Responsible for making this declaration is the:
Manufacturer
Authorised representative established within the EU
Person responsible for making this declaration
Print name/Title:
Kevin Tan/R&D management
Guangdong Transktek
Medical Electronics Co.,Ltd
2017.9.20
Safety
Article3.1(a)
EMC
Article3.1(b)
Draft EN 301 489-1 V2.2.0, Draft EN 301 489-17 V3.2.0
Radio
Article3.2
EN 300 328 V2.1.1, Draft EN 303 345 V.1.1.7
Health
Article3.1(a)
EN 62479: 2010
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