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 No: 21IMJI32
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 AND DISTRIBUTION OF MEDICAL DEVICES.
Initial Registration Date: 21/12/2021 Issuance Date: 21/12/2022 Date of Expiry: 20/12/2023 Date of Re-Certification: 20/12/2024 Certified by: AQC Middle East LLC - Member of IAF and IAS Accredited.
ISO9001:2015 Certificate No: 24EQNV54
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: 19 October 2024
SAHPRA Licence Number: 00001652MD_v1
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. Amendment date: 17 May 2024 Expiry date: 27 October 2025
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.