CERTIFICATES

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

ASSOCIATIONS

Malaysia External Trade Development Corporation (MATRADE)

Federation of Malaysian Manufacturers

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