Certifications & Compliance
Every OxiHaven product line is manufactured to medical-grade standards. The documents below can be verified online; medical clients and distributors may download the full document package for procurement and tender processes.
ISO 13485CENMPA RegistrationPressure Vessel TestingISO 9001
Management System Certifications
ISO 13485 Medical Device QMS CertificationCovering design, development and manufacturing of all product lines (cert. no. placeholder)
View CertificateISO 9001 Quality Management SystemFactory-wide quality management system (cert. no. placeholder)
View CertificateProduct Certifications & Registrations
CE Conformity (Home / Commercial / Veterinary Series)EU market access · issued by notified body (cert. no. placeholder)
View CertificateNMPA Medical Device Registration (Medical Series)China National Medical Products Administration · Class II/III (per actual certificate)
View CertificateTest Reports
Chamber Pressure Test ReportThird-party testing institute · 150% safety redundancy pressure test
View ReportOxygen Concentration Test Report93%±3% stability · tested unit by unit before shipment
View ReportCompliance Notes
Classification and market-access requirements for hyperbaric equipment vary by country/region. OxiHaven provides the corresponding documentation package and registration support for each target market; medical efficacy claims strictly follow the approved registration scope.