HPO.TECH hyperbaric chambers are built and certified to recognised international standards for safety and quality. These are the certifications that back that up - and worth looking for on any chamber.
Which medical-device approvals apply depends on the market and how a chamber is supplied. Tell us the model and where it's going, and we'll confirm exactly where it stands - in writing.
Each of these confirms a specific safety or quality requirement. They are the marks that separate a certified chamber from an unverified one.
CE marked against the applicable EU health, safety and environmental requirements for sale on the European market - assessed, not self-declared.
Manufactured to the internationally recognised quality management standard for medical devices, so every chamber is built to the same audited process.
Certified under European pressure-equipment regulation to safely handle the pressures hyperbaric therapy uses.
Every unit independently inspected and pressure-tested for structural integrity by a classification body, before it leaves the factory.
Designed and built to the ASME PVHO standard - written specifically for pressure vessels that safely hold people under pressure.
Meets NFPA fire-safety guidance for hyperbaric chambers, covering fire prevention and suppression.
Where chambers are supplied as medical devices, HPO.TECH holds the relevant market authorisations - with more added as the range expands into new territories.
HPO.TECH is transitioning from the Medical Devices Directive (MDD) to the EU Medical Device Regulation (MDR).
European UnionEvery system meets the UAE's medical and technical standards, registered with the Ministry of Health and Prevention.
United Arab EmiratesFull marketing authorisation held in the Kingdom, cleared by the Saudi Food and Drug Authority.
Saudi ArabiaMeets Malaysia's regulatory standards for medical devices, registered with the Medical Device Authority.
MalaysiaPersonal and wellness chambers and medically-classified chambers sit under different frameworks, and the approvals that apply change by country. Rather than round it up, we set out the exact certification position for your model and market in writing - so you know precisely what you're buying.
See what to look for in a chamberTell us the model and the market. We'll confirm its exact certification position and share the documentation.
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