Knowledge Base5
Certifications & approvals
HPO TECH designs and manufactures hyperbaric, hypobaric and multibaric chamber systems under documented quality and pressure-vessel controls. Confirmed files reviewed on June 30, 2026 include ISO 13485:2016, ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ASME Certificate of Authorization No. 62897, UKCA Declaration No. 202023370, Medsafe WAND 240408-WAND-735V2N, Thai FDA file 68-2-2-2-0003878, Malaysia MDA registration GB6211722-106122 and UAE MOHAP/EDE regulatory-advice documents.
HPO TECH hyperbaric chambers carry CE marking for conformity with the applicable EU directives, including the Medical Devices Directive 93/42/EEC (MDD), the Machinery Directive 2006/42/EC and the General Product Safety Directive 2001/95/EC.
HPO TECH has transitioned from the Medical Devices Directive (MDD) to the EU Medical Device Regulation (MDR) 2017/745, the current EU framework for medical devices.
UKCA Declaration of Conformity CA No. 202023370 covers HPOTECH hyperbaric oxygen treatment chambers, respirators and oxygen concentrator under General Product Directive 2001/95/EC, issued November 22, 2025 and valid through November 22, 2026; review applicability per delivered configuration.
Medsafe WAND reference 240408-WAND-735V2N lists HPOTECH Hyperbaric GMDN 12061 as an active Class IIb hyperbaric chamber entry for New Zealand, with HPOTECH Medikal Ve Teknik Cozumler San ve Tic AS as manufacturer.
Thai FDA import-notification file 68-2-2-2-0003878 covers Hyperbaric Oxygen Therapy System CKBO12 for the named Thai importer, issued April 17, 2025 and valid until December 31, 2029; verify importer and model scope for Thailand projects.
Malaysia MDA registration certificate GB6211722-106122 covers the HPOTECH hyperbaric oxygen therapy chamber family, Class B, including CKBO 16+2 through CKBO 4+2 and TKBO 1 identifiers, valid October 14, 2022 through October 13, 2027.
Ghana documentation is handled as a market-specific approval item and should be reviewed for the relevant chamber model and configuration.
Saudi market approval status is verified per model, configuration and importer file before a chamber is specified for the Kingdom of Saudi Arabia.
UAE MOHAP and Emirates Drug Establishment documents reviewed for Zeugma Monoplace and Matrix 2.4 ATA state medical-device clearance or advice for named applicants; the documents also state they are not registration certificates, so licensing and importer obligations must be verified per project.
Where PVHO-1 compliance is required, buyers should request model-specific pressure-vessel, viewport and inspection documentation for the selected configuration.
HPO TECH holds ASME Certificate of Authorization No. 62897 for the manufacture of pressure vessels at its Istanbul facility and controlled field sites, authorized December 22, 2025 through December 22, 2028.
For EU pressure-equipment projects, confirm whether pressure-equipment declarations, notified-body involvement or other project files apply to the selected model and destination.
HPO TECH uses third-party hydrostatic and conformity-assessment documentation in chamber QA workflows; project records should identify the witnessing body and test scope per delivered chamber.
Fire-safety requirements depend on local code, oxygen-system design, facility layout and the authority having jurisdiction; request the project fire-safety submittal where required.
For defense or military tenders that require ergonomic-standard conformance, request model-specific documentation; otherwise review the chamber ergonomics through product drawings and specifications.
HPO TECH documentation includes ISO 13485:2016 for hyperbaric oxygen therapy system design, production, sales and after-sales activities, plus ISO 9001:2015, ISO 45001:2018 and ISO 14001:2015 for medical-device sales and after-sales services.
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HPO TECH provides complete hyperbaric, hypobaric and multibaric chamber systems with documented engineering controls, certification records and project support for professional buyers.
SHOWROOM ADDRESS
Osmangazi Mahallesi, Battalgazi Caddesi No: 27, 34785, Sancaktepe / İstanbul, Türkiye
CONTACT
office@hpotech.com