What CE really means for a hyperbaric chamber
Almost every product in this market carries the word CE. On its own that says little. What to ask for, what we supply with every system, and why none of our chambers is a medical device.
In this market almost every product carries the word CE. On its own that says little. What matters is whether a signed declaration of conformity sits underneath it, which directives were assessed, and whether the exact model is named in the documents.
Three questions to ask any supplier
- Is there a signed EU declaration of conformity? Not a logo on a brochure, but a document signed by the manufacturer that names the model.
- Which directives were assessed? For a hyperbaric chamber with electrical peripherals that typically means the Low Voltage Directive and the EMC Directive, with the relevant EN IEC standards.
- Is the exact model named? A certificate for a product family is not the same as a certificate for the chamber in your room.
What we supply
With every system we supply the full conformity file and tell you in advance what is in it. The ULTRA, for example, carries an EU declaration of conformity signed by the manufacturer, assessment under the Low Voltage Directive 2014/35/EU and the EMC Directive 2014/30/EU, an ISO 13485:2016 quality system issued by TÜV SÜD and an electrical safety and performance report tested to IEC 60601-1.
On handover you receive the conformity file, the manual, the safe-use instructions and the maintenance schedule. If an insurer, occupational health service or regulator asks, you can show immediately what you have on site.
Training and wellness equipment, fully documented
None of the systems in our overview is a medical device under the MDR. Our systems are certified training and wellness equipment, used in recovery centres, clinics, sports clubs and premium homes. We explain how the technology works, what users experience and how it fits into your programme.
For applications where medical certification is required we supply medically certified hyperbaric chambers from HPO TECH. Those systems are configured per project.
Read more on our certification page, or contact us with a question about a specific model.
