SUPERMAX CERTIFICATIONS

FDA 510k Registration
*US Food & Drug Administration

Europe CE 0120 Mark Directive 93/42/EEC
*SGS United Kingdom Ltd

Therapeutic Goods Administration, Australia
*TGA Australia

NF 101 Standards, France
*French AFNOR Certification

CMDCAS ISO 13485 : 2003
*SGS System & Services Certification Canada Inc.

EEC Commission Directive 90/128/EEC
*SGS United Kingdom Ltd

Standard Malaysian Glove (SMG)
*Malaysian Rubber Board, Malaysia

Europe CE 0120 Mark Directive 89/686/EEC
*SGS United Kingdom Ltd

Canadian General Standards Board Listing
*CGSB, Canada

Medical Device Licence, Canada
*Medical Device Bureau, Health Canada

Quality Management System ISO 9001: 2000
*SGS United Kingdom Ltd

Quality Management System ISO 9001: 2000
*SIRIM QAS International Sdn Bhd, Malaysia