ISO13485 Medical Device PSA Oxygen Generator 30Nm3/h 93% Purity CE Certified for

The PSA Medical Oxygen Generator is purpose-built for large-scale hospital procurement and government healthcare infrastructure projects. Manufactured under Luoming's ISO 13485 medical device quality management system with ISO 9001 and CE certifications, this 30Nm³/h system delivers 93% ±3% medical-grade oxygen with complete regulatory documentation—eliminating compliance risks and accelerating project timelines from purchase order to operational handover.

Hospital and government procurement increasingly mandate ISO 13485 certification and CE marking as non-negotiable prequalification criteria. Our system meets and exceeds these requirements. The ISO 13485 certification covers the entire product lifecycle—design, manufacturing, testing, packaging, and post-market surveillance—giving tender evaluation committees the documented evidence they need to approve your bid. With a comprehensive technical dossier, CE Declaration of Conformity, factory audit reports, and third-party test records included as standard, this system transforms regulatory compliance from a procurement bottleneck into a competitive advantage.

One of the biggest challenges in international medical device trade is navigating diverse regulatory landscapes. Our system addresses this with a universal compliance framework built on ISO 13485 and CE certification—two standards recognized or harmonized by health authorities in Europe, the Middle East, Southeast Asia, Africa, and Latin America. Each shipment includes a pre-assembled regulatory package: ISO certificates with accredited body verification, CE for EU market access, material and component traceability records, factory acceptance test (FAT) reports, and installation qualification (IQ) and operational qualification (OQ) templates. For local health authorities, this means faster document review, fewer clarification requests, and confidence in issuing operational permits for the installed system.

With an oxygen output of 30Nm³/h at 93%±3% purity, this system is sized to meet the demands of medium to large hospitals with 200-500 beds, covering central pipeline supply to wards, ICUs, operating theaters, and emergency departments simultaneously. The PSA twin-tower design with PLC automatic control ensures uninterrupted 24/7/365 operation. Built-in remote monitoring capability allows hospital engineering teams and Luoming's after-sales support to track system status in real time, enabling predictive maintenance and rapid response—critical features that further strengthen tender technical evaluation scores.

• ISO 13485 Medical Device Certified: Design, production, and servicing under audited quality management system
• CE Marked with Full DoC: Complete conformity documentation for EU and harmonized markets
• ISO 9001:2015 Certified: Enterprise-wide quality management across all functions
• Tender-Ready Documentation: Pre-assembled regulatory package reduces bid preparation time
• 30Nm³/h Capacity: Suitable for 200-500 bed hospitals with central pipeline supply
• Global Recognition: Certifications accepted by health authorities across Europe, MENA, ASEAN, and Africa
• FAT Reports Included: Factory acceptance test data validates performance before shipment
• Remote Monitoring Capable: Networked PLC enables real-time oversight and predictive maintenance