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ISO 9001:2015 Quality Management System
Certificate no.: 01 100 086127
CE0197
Directive 93/42/EEC Annex V
Production Quality Assurance Medical Devices
Registration No.: DD 60147888 0001
EN ISO 13485:2016 Medical Devices – Quality Management System
Certificate No.: SX 2958691-1
www.fsc.org
FSC® C105797
The mark of responsible forestry
Forest Stewardship Council®
US FDA Registered
US FDA Registration Number: 3007483363
Certified to Good Distribution Practice for Medical Devices
(MDA/RR No.1:2015)
Cert. No.: GDPMD 00347
Malaysia External Trade Development Corporation (MATRADE)
Federation of Malaysian Manufacturers