Certifications
AlkoSafe Certifications & Quality Standards
AlkoSafe is manufactured to international quality standards backed by independent certification. This page explains what each certification means and how to verify our claims.
Certification
CE Mark — European Conformity
What this certification covers and what it means for you as a buyer.
The CE Mark is the manufacturer’s declaration that AlkoSafe meets the health, safety, and environmental protection requirements of applicable European directives. CE marking allows a product to be placed on the market in the EU and Turkey.
For AlkoSafe, CE marking means the product has been evaluated for safety and performance, the manufacturing processes meet European standards, and technical documentation is maintained for regulatory inspection.
CE marking creates legal accountability — if a CE-marked product causes harm due to non-compliance, the manufacturer bears full legal responsibility.
Safety Assessed
Product evaluated against European safety and performance standards
Documentation
Technical documentation exists, is maintained, and available for inspection
Legal Accountability
Manufacturer accepts full legal responsibility for compliance
Market Access
Legally sold in Turkey and all European markets
Regulatory Oversight
Authorities can request inspection of supporting documentation at any time
Quality Standard
ISO 13485:2016
ISO 13485:2016 is the internationally recognised standard for quality management systems in the medical device industry. It specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
AlkoSafe is manufactured under an ISO 13485:2016 certified quality management system. This means every stage — from raw material sourcing to final packaging — is controlled, documented, and auditable.
Batch Controls
Every batch under documented quality controls
Qualified Suppliers
Merck & Sartorius qualified and monitored
Full Traceability
Every batch traced from raw material to product
Non-Conformance
Issues recorded, investigated, corrected
External Audits
Audited by accredited external body
Post-Market
Ongoing product performance monitoring
Materials
Swiss & German-Grade Materials
The core reactive membrane in every AlkoSafe strip is nitrocellulose sourced from Sartorius (Germany) and treated with reagents from Merck (Switzerland/Germany). These are the same suppliers used in European hospital-grade diagnostic devices.
By using the same raw materials as professional laboratory tests, AlkoSafe achieves clinical-grade sensitivity in a consumer-friendly format. Every incoming material batch is tested and documented before production begins.
Downloads
Certificate Downloads
CE Declaration of Conformity
Download PDF
ISO 13485:2016 Certificate
Download PDF
Product Technical Sheet
Download PDF
Questions? Contact info@alkosafe.com
Don't Guess. Test.
AlkoSafe gives you a clear answer in 2 minutes. Protect yourself, your licence, and the people around you.
99.7%
Sensitivity
2 min
Result Time
0.2 Promil
Detection Threshold
24 mo
Shelf Life
Important: AlkoSafe is a personal screening tool for individual decision-making. It is not a substitute for official law enforcement breathalyser or blood tests. A negative AlkoSafe result cannot be used to challenge a positive police test in court. If AlkoSafe shows any colour change, do not drive. Always wait at least 15 minutes after eating, drinking, or smoking before testing.
