We are pleased to advise that we have achieved ISO13485:2016 Registration and hold a SAHPRA Licence Number: 00001652MD_R1: Alcohol Breathalysers Pty Ltd, situated at 29 Plantation Road, Corner 48 The Avenue, The Gardens, Norwood, 2192 is a Licenced Distributor, Importer and Exporter of Medical Devices including Class B devices. Validity Original Date of Issue: 27 October 2020. 1st Renewal date: 21 October 2025 Expiry date: 21 October 2030
ISO13485:2016 Certificate of Registration - Certificate No: MD-1208
The Medical Device Quality Management System of Alcohol Breathalysers (Pty) Ltd has been assessed and found to conform to the requirements of ISO13485:2016 for the following scope: THE IMPORT, EXPORT, DISTRIBUTION, SALES, TRAINING, SERVICING, REPAIR AND CALIBRATION OF MEDICAL DEVICES - ALCOHOL BREATHALYSERS AND BREATH KETONE MONITORS.
Initial Registration Date: 1 December 2025, Issue Date: 1 December 2025 Date of Expiry: 30 November 2028 Next Audit Date: 30 November 2026 Certified by: Transpacific Certifications Limited (TCL) - Member of IAF.
