ETA 3297 90000 User Manual
DECLARATION OF CONFORMITY
TO COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993
CONCERNING MEDICAL DEVICES
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 MONITORS：TMB-1490-CS
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 ATTACHED
NOTIFIED BODY: TÜV SÜD PRODUCT SERVICE GMBH
RIDLERSTR 65, D-80339 M NCHEN, 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: 2018-6-22
PLACE, DATE OF DECLARATION: ZHONGSHAN，2018-6-22
SIGNATURE: NAME:
POSITION:R&D DIRECTOR
Page 1 of 2 Ver:A/0 LS-DOC-0003-TMB-1490-CS
DECLARATION OF CONFORMITY
Risk management
EN ISO 14971:2012
Labeling
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
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
Chemical control
RoHS Directive 2011/65/EU
TO COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993
CONCERNING MEDICAL DEVICES
Standards applied:
Page 2 of 2 Ver:A/0 LS-DOC-0003-TMB-1490-CS
Loading...