Choosing an ozone sauna
What does CE marking mean on an ozone sauna, and what does it cover?
Each of our current models (Standard, Deluxe and Red Light) carries CE marking. CE marking is the manufacturer's declaration that the product meets EU product-safety rules; it is not a medical approval. We can send the Declaration of Conformity for your model on request.
What CE marking is. A declaration by the manufacturer that the product conforms to the applicable European Union directives for health, safety and environmental protection, allowing it to be placed on the European market. For most product categories it is self-declared against the relevant standards, with a technical file to support it.
Our position. We sell our ozone saunas as wellness equipment, not medical devices. Each of our current models (Standard, Deluxe and Red Light) carries CE marking. CE marking is the manufacturer’s declaration that the product meets EU product-safety rules; it is not a medical approval. We can send the Declaration of Conformity for your model on request. The oxygen concentrator supplied with the sauna is a medical device in its own right. The model we currently supply is FDA-cleared and CE marked. The FDA clearance applies to the concentrator, not to the sauna.
What CE marking is not.
- It is not a medical device approval, and it is not the same as certification by a notified body under the EU Medical Device Regulation.
- It is not a US Food and Drug Administration clearance, a Therapeutic Goods Administration listing in Australia, or a South African Health Products Regulatory Authority registration. Those are separate processes, market by market.
- It is not evidence of clinical benefit.
Grade claims are not certification either. A grade adjective means nothing unless a standard is named. Ours are specific: 304 and 316 stainless steel and silicone in the gas path. Ask any manufacturer to be that specific.
What to ask for. A current Declaration of Conformity naming the model you are buying, the standards it was assessed against, and the date. If a seller cannot produce the paperwork, treat the claim as unverified. That applies to every manufacturer, us included.
Regulatory status is a separate question. Ozone therapy is regulated differently in every market, and in some it is not approved as a medical treatment at all. Whether a device is CE marked has no bearing on whether you may lawfully offer ozone therapy commercially where you live. If you are buying for a clinic or spa, check the local position on both the equipment and ozone therapy before you order.
Terms used