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Distributed by:
SHINEMART LTD Unit 1, Spilsby Road, Harold Hill, Romford, Essex, RM3 8SB UK
Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd.
Company: Guangdong Transtek Medical Electronics Co., Ltd.
Address: Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Authorized European Representative:
Company: MDSS - Medical Device Safety Service GmbH
Address: Schiffgraben 41, 30175 Hannover, Germany
Complied European Standards List
Risk Management
Labeling
User Manual
Generl Requirements for Safety
Electromagnetic Compatibility
Performance requirements
Clinical investigation
Software Lifetime
Usability

Contact Information

23
ISO/EN 14971:2012
ISO/EN 15223-1:2012
EN 1041:2008
EN 60601-1:2006
IEC/EN 60601-1-11:2010
IEC/EN 60601-1-2:2007
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN 1060-4:2004
IEC/EN 62304:2006+AC:2008
IEC/EN 60601-1-6:2010
IEC/EN 62366:2007

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