CE marking
European regulatory benchmark for the devices concerned. It indicates that the product is placed on the market within the applicable framework.
Regulatory frameworkLabels, standards, and certifications AMA Prévention
Understanding our labels
Labels, standards, and certifications: what are they for our clients?
The logos displayed on our product sheets are not decorative. They help individuals, companies, communities, and health professionals understand the origin of the products, the regulatory framework, the manufacturer quality level, and the usage limits.
This page simply explains what the main labels, standards, and certifications used by AMA Prévention mean, without overinterpreting them. A logo must always be read with its exact scope: concerned product, manufacturer’s instructions, technical data sheet, or associated official document.
ISO 13485
Manufacturer quality benchmark for medical devices. It concerns the quality organization, not a promise of infallibility.
Manufacturer quality
Used by the French Armed Forces
Mention linked to a specific reference, notably Drugdiag® Saliva 5+ when the product documentation specifies it.
Institutional use
Heart of Alsace
Regional and territorial anchoring benchmark of AMA Prévention. It is not a medical or technical product certification.
Territorial anchoringCE marking: what it means for a client
A regulatory benchmark, not a magic guarantee
The CE marking indicates that the device concerned is placed on the market within the applicable European regulatory framework. For a client, it is a first compliance benchmark: the product is not presented as a simple gadget but as a device registered within a defined framework.
What it proves
The product concerned follows a market placement framework and must be accompanied by instructions, intended use, and interpretation limits.
Compliance
What it does not prove
CE does not mean that a rapid test is infallible, that it replaces a laboratory, or that it allows an automatic medical or legal decision.
LimitationsKey point: the CE marking must be linked to the specific product. It should not be generalized to an entire range without checking the technical data sheet or instructions.
ISO 13485: understanding manufacturer quality
A standard linked to the quality system
ISO 13485 is a quality management standard for medical devices. For a professional client, it indicates that the manufacturer operates in a structured quality environment: traceability, documentation, process control, and requirements specific to medical devices.
What it brings
A reliable benchmark on the manufacturer's quality organization, useful for professional purchases, tenders, and internal quality processes.
Quality
What this does not replace
The standard does not replace the leaflet, the test thresholds, storage conditions, or analytical confirmation in case of disputed results.
LeafletUsed by the French Armed Forces: exact scope
A strong mention, to be linked to the right product
The mention “Used by the French Armed Forces” is important as it signals operational trust. However, it must remain linked to the relevant reference, notably the Drugdiag® Saliva 5+ when the product documentation specifies it.
What this highlights
Use by a demanding institution, in a context where reliability, readability, and robustness of the device matter.
Trust
What to avoid
Extend this mention to all urinary tests, NPS, breathalyzers, or other products if the documentation does not specify it.
ClarificationCœur d’Alsace: AMA Prévention’s local roots
A territorial marker, not a product certification
The Cœur d’Alsace label highlights AMA Prévention’s regional roots and its attachment to the Alsace territory. It helps understand the company’s identity, its closeness, and its local commitment.
What this means
AMA Prévention is a company based in Alsace, with a commitment to proximity, commercial seriousness, and customer support.
Territory
What this does not mean
Cœur d’Alsace is not a medical certification, a CE marking, a regulatory validation, or a technical proof of test performance.
Clear limitBreathalyzers: standards and maintenance
A breathalyzer must be verified model by model
Chemical breathalyzers, consumer electronic, professional electronic, and prevention stations do not all have the same use. Standards, maintenance, calibration, mouthpieces, and measurement conditions must be checked on the relevant model’s sheet.
Chemical breathalyzer
Convenient for preventive distribution or occasional self-testing, to be used under the conditions specified in the leaflet.
Electronic breathalyzer
Suitable for repeated use, but dependent on maintenance, mouthpieces, time after consumption, and the planned calibration.
Breathalyzer station
Collective solution for events, companies, and communities, to be integrated into a structured prevention approach.
Safety note: a breathalyzer should never be presented as a driving authorization. In case of doubt, do not drive.
Thresholds and matrices: why the leaflet remains essential
Saliva, urine, NPS: do not mix frameworks
A saliva threshold, a urinary cut-off, an NPS panel, or a blood alcohol measurement do not serve the same purpose. To avoid errors, thresholds must be read on the product sheet and the leaflet of the batch used.
Saliva
More oriented towards recent consumption depending on substances and usage context.
Urine
Search for markers or metabolites in a window often different from saliva.
NPS
Panels target certain families of new substances without covering all existing molecules.
How to verify information before purchase?
The right method for a professional purchase
1. Check the product sheet
Detected substances, matrix, confirmed thresholds, intended use, and limits.
2. Read the instructions
It specifies reading, timing, possible reactions, storage, and limits.
3. Request the documents
For a tender or sensitive use, request the appropriate certificates, instructions, and technical datasheets.
Need help: AMA Prévention can support companies, communities, and professionals in choosing the right device according to the real usage context.
Useful references for professionals
Texts and frameworks to consult
These references help understand the general framework. They do not replace the manufacturer’s instructions nor legal advice tailored to a specific situation.
Regulation (EU) 2017/746
European framework for in vitro diagnostic devices. View EUR-Lex
Order of December 13, 2016
French reference related to saliva drug screening in road contexts. View Legifrance
Labor Code L.4121-1
General obligation of prevention and safety for the employer. View the article
Council of State No. 394178
Jurisprudential reference on saliva tests in companies under strict conditions. View the decision
Frequently asked questions
Understand without overinterpreting
Does the CE make a test infallible?
No. It indicates a regulatory framework for the device concerned but does not remove usage or interpretation limits.
Does the UAF cover the entire range?
No. This mention must remain attached to the concerned product, especially Drugdiag® Saliva 5+ when specified in the documentation.
Is Cœur d’Alsace a medical certification?
No. It is a territorial and regional reference, not a medical certification nor a technical validation of the tests.
Why check thresholds sheet by sheet?
Because a threshold depends on the matrix, the test, the panel, the instructions, and the usage context.
Page written and updated by the AMA Prévention team. Information should be interpreted according to manufacturer instructions, technical datasheets, applicable texts, and usage context.