Operation Manual

170
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-1597-BN
Software:
A01
Accessories:
Adapter(Model:)KH0601000EW; battery
：
4*AA
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 NB No.: 0168 certificate No.: BABT-RED000465 i01
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 2017.7.21
Safety
Article3.1(a)
EMC
Article3.1(b)
Draft EN 301 489-1 V2.2.0 (2017-03
）
Draft EN 301 489-17 V3.2.0 (2017-03)
Radio
Article3.2
EN 300328 V2.1.1(2017-03)
Health
Article3.1(a)
EN 62479:2010