ETA SMART 4297 90000 User Manual
DECLARATION OF CONFORMITY
TO COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993
CONCERNING MEDICAL DEVICES
Page 1 of 2 Ver: A/0 LS-DOC-0003-TMB-1583-BS
MANUFACTURER： NAME: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.
ADDRESS: ZONE A, NO.105, DONGLI ROAD, TORCH
DEVELOPMENT DISTRICT, ZHONGSHAN, GUANGDONG, CHINA
MEDICAL DEVICE: BLOOD PRESSURE MONITOR：TMB-1583-BS
CLASSIFICATION - ANNEX IX: CLASS IIA, RULE 10
CONFORMITY ASSESSMENT ROUTE: MDD ANNEX II EXCLUDING (4)
WE, THE MANUFACTURER, HEREWITH DECLARE THAT THE STATED MEDICAL DEVICES
MEET THE TRANSPOSITION INTO NATIONAL LAW, THE PROVISIONS OF COUNCIL DIRECTIVE
93/42/EEC OF 14 JUNE 1993 CONCERNING MEDICAL DEVICES;
INCLUDING, AT 21 MARCH 2010, THE AMENDMENTS BY COUNCIL DIRECTIVE 2007/47/EEC.
ALL SUPPORTING DOCUMENTATION IS RETAINED AT THE PREMISES OF THE MANUFACTURER.
THE MANUFACTURER IS EXCLUSIVELY RESPONSIBLE FOR THE DOC.
STANDARDS APPLIED: SEE THE FOLLOWING STANDARDS ATTACHED
NOTIFIED BODY: TÜV SÜD PRODUCT SERVICE GMBH
RIDLERSTR 65, D-80339 MÜNCHEN, GERMANY
IDENTIFICATION NUMBER
(EC) CERTIFICATE(S): NO.G1 16 11 82800 026
EUROPEAN REPRESENTATIVE: MDSS-MEDICAL DEVICE SAFETY SERVICE GMBH
SCHIFFGRABEN, 41,30175, HANNOVER, GEMANY
START OF CE-MARKING: 2018-11-15
PLACE, DATE OF DECLARATION: ZHONGSHAN，2018-11-15
SIGNATURE: NAME: KEVIN TAN
POSITION: R&D DIRECTOR
DECLARATION OF CONFORMITY
TO COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993
CONCERNING MEDICAL DEVICES
Page 2 of 2 Ver: A/0 LS-DOC-0003-TMB-1583-BS
Standards applied:
Risk management
EN ISO 14971:2012
Labelling
EN ISO 15223-1:2016
User manual
EN 1041: 2008 +A1:2013
General requirements
for safety
EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012
EN 60601-1-11:2015/ IEC 60601-1-11:2015
Non-invasive
sphygmomanometers
General requirements
EN ISO 81060-1:2012
EN 1060-3:1997+A2:2009
IEC 80601-2-30: 2009+A1:2013
Electromagnetic
compatibility
EN 60601-1-2:2015/ IEC 60601-1-2:2014
Usability
EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013
EN 62366-1:2015 + AC:2015/IEC 62366-1:2015 + COR1:2016
Software life-cycle
EN 62304:2006 + A1:2015/IEC 62304:2006+A1:2015
Biological evaluation
EN ISO 10993-1:2009
EN ISO 10993-5:2009
EN ISO 10993-10:2010
Clinical Investigation
MEDDEV.2.7.1: 2016
ISO 81060-2:2013
Hazardous material
control
RoHS Directive 2011/65/EU
RED
EN 301 489-1 V2.1.1
EN 301 489-17 V3.1.1
EN 300 328 V2.1.1
EN 62479: 2010
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