35
Labelling and Symbols
The Legal Manufacturer is Kangfu Medical Equipment Factory, No.380 Ningkang East Road,
Yueqingzhejiang, China 325600.
UK Dist
Distributor in the UK: Aseptika Limited (Activ8rlives): Suite 5, LDH House, St Ives Business Park,
Parsons Green, St Ives, Cambridgeshire, PE27 4AA, UK.
Date of
Manufacture
2019
-
03.
Model
Digital Blood Pressure Monitor
BLUECS80B
(25
-
48cm) and
PINKCS80B
(17
-
32cm).
CS80B20190330.
Battery
3.7V, 800mAh polymer lithium
-
ion battery.
This product is a certified Class IIa medical device and complies with the requirements of Directive
93/42/EEC, amended by 2007/47/EEC.
EN ISO 13485:2016 Medical Device certification.
CFDA is responsible for registration of medical devices for the Chinese market.
Attention, see Instructions for use.
In accordance with IEC 60601
-
1 the product and its applied parts type BF and thus protected against
the risks of electrical leakage.
RoHS Directive (2011/65/EU), amended by 2015/863/EU.
The symbol in accordance with IEC EN 60601
-
1
-
2: 2007 in section 5.1.1 for products including RF
transmitter.
This symbol is required by European directive 2002/96/EEC on waste electrical and electronic
equipment (WEEE). At the end of its useful life this device must not be disposed of as normal
domestic waste. Instead it must be delivered to a WEEE authorised collection centre. Due to the
construction materials used for the device, disposal as normal waste could cause harm to the
environment and/or health.
Read instructions before use.
EC REP
European Representative: Lexus Lebenswelt GmbH, Kochstrasse 1, 47877 Willich, Germany.
0123
