ISO13485 CE Certified PSA Medical Oxygen Generator 10Nm3/h 93% Purity for Hospital Regulatory Compliance

The PSA Medical Oxygen Generator is manufactured by Jiangsu Luoming Purification Technology Co., Ltd under a rigorous ISO 13485 Medical Device Quality Management System and holds ISO 9001 and CE certifications. Every unit ships with a complete technical documentation package, enabling fast customs clearance and seamless local regulatory authority acceptance in target markets worldwide.

ISO 13485 is the internationally recognized standard for medical device quality management systems, setting stringent requirements for design, production, installation, and servicing. Luoming's ISO 13485 certification means our medical oxygen generators are manufactured under controlled, documented, and audited processes that meet the expectations of healthcare regulators globally. From raw material traceability to final factory acceptance testing, every unit undergoes a fully documented quality journey -- giving hospital procurement teams and regulatory authorities complete confidence in product safety and performance.

Every shipment is accompanied by a complete regulatory documentation package designed to accelerate the approval process in destination countries. This includes ISO 13485 and ISO 9001 certificates, CE Declaration of Conformity, factory audit reports, material traceability records, performance test data, installation and operation manuals, and maintenance guidelines. For hospital procurement departments and local health authorities, this means faster verification, fewer queries, and shorter time-to-operation -- critical factors when deploying life-saving medical infrastructure.

• ISO 13485 Certified: Manufactured under medical device quality management system standards
• CE Marked: Full compliance with European health and safety directives
• ISO 9001 Certified: Quality management across all business processes
• Complete Documentation: Technical dossier, DoC, certificates, and test reports included
• Stable 93% ±3% Purity: PSA technology with continuous in-line purity monitoring
• Fully Automatic PLC Control: Unattended operation with real-time monitoring
• Global Market Ready: Certified for Europe, Middle East, Southeast Asia, Africa, and Latin America
• Fast Customs Clearance: Pre-prepared regulatory documentation reduces border delays

Located in Yancheng City, China, Luoming Purification Technology is an ISO 13485 and ISO 9001 certified manufacturer specializing in air separation and medical gas generation equipment. Our product portfolio includes PSA Oxygen Generators, PSA Nitrogen Generators, and complete medical gas solutions deployed in hospitals across 90+ countries. Every Luoming medical oxygen generator is produced under strict quality controls with full material traceability, comprehensive testing, and complete regulatory documentation--ensuring our partners worldwide experience smooth customs clearance and rapid regulatory acceptance.

• Q: What documentation do you provide for customs clearance?
  A: Each shipment includes ISO 13485 certificate, ISO 9001 certificate, CE Declaration of Conformity, technical datasheets, factory test reports, and packing lists. We can also provide country-specific documentation upon request.
• Q: Does your ISO 13485 certification cover medical oxygen generators specifically?
  A: Yes. Our ISO 13485 certification scope specifically covers the design, manufacture, and servicing of medical gas generation equipment, including PSA oxygen generators for hospital use.
• Q: How does certification help with hospital procurement?
  A: ISO 13485 and CE certifications are often mandatory requirements in hospital tenders and government procurement frameworks. Having these certifications pre-validated significantly reduces the evaluation time and technical queries from procurement committees.
• Q: Can you provide additional country-specific certifications?
  A: Yes. Depending on your target market, we can assist with additional regulatory approvals and provide supplementary testing or documentation as required by local health authorities.