Approvals & Certifications
ISO17025:2017 Certificate No: RSA20230101
Certificate of Accreditation, Laboratory Management System, has been issued to Alcohol Breathalysers (Pty) Ltd, 29 Plantation Road, Corner of 48 The Avenue, The Gardens, Norwood, Johannesburg, South Africa, under The Testing and Calibration Laboratories Program in Accordance with ISO17025:2017. The Certificate is applicable to the following Product or Service ranges: CALIBRATION OF BREATHALYSERS Period of Certification: 31 January 2024 to 30 January 2025. Certificate Number: RSA20230101
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.
ISO9001:2015 Certificate of Registration - Certificate No: 19618
The Quality Management system of Alcohol Breathalysers (Pty) Ltd has been assessed and found to conform to the requirements of ISO9001:2015
Date of Registration: 1 December 2025
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
OEM Manufacturer ISO Quality Assurance Certifications: Our Alcoscan, iSober and iBlow10 alcohol breathalysers are manufactured by Sentech Korea Corporation and the Environmental Management System and Quality Management Systems in place have been certified by KMAR to standards ISO9001 and ISO14001 respectively.
EN Standard 15964:2011 for Breath alcohol test devices other than single use devices: Alcoscan ALP-1 meets the requirements of EN15964:2011 and we have a Conformance Report Available from the SABS Environmental Testing department.
ICASA Approval of Bluetooth (BT) and Bluetooth Low Energy (BLE) obtained for the following breathalyser models and accessories:
Alcoscan ALP-1 (BT), YJ Printer (BT) for Alcoscan ALP-1 (BT), iSoberS Pro (BLE), Alcoscan AL8800BT (BLE), KETOSCAN Mini (BLE), Multigenix Ketoscan Smart and iBlow10 Pro BLE.
EMC EN 61326-1:2006 compliant:
All of the electronic products which we sell include the CE mark and application of the CE mark is permitted.
Important Notice regarding "SABS Approval" and "Department of Transport (DOT) Approved" Breathalyser Screeners in South Africa:
There exists no SABS Standard for breathalyser screening devices in South Africa therefore no "SABS Approval" can be given to any breathalyser screener in South Africa.
Only Evidential Breath Analyser Testers (EBATs) specifically required for Road Traffic Law-Enforcement Prosecutions in terms of the National Road Traffic Act 1996 can be "SABS Approved" when they are type-approved against SABS1793:2013. The SABS Environmental Testing department may in some instances issue "Conformance Reports" relating to foreign International Standards for Breathalyser Screeners however these Conformance Reports are not considered "SABS Approvals".
Any South African company which claims that they sell an "SABS Approved" or "Department of Transport (DOT) Approved" Breathalyser Screener is making a false, illegal and fraudulent claim about their breathalyser product.