GNEE PSA Medical Oxygen Generators Depart for Europe, Fortifying Overseas Medical Oxygen Supply Lines

Breaking Through Medical Access Barriers: Entering the European Market with Rigorous Compliance

Customer Needs Focus on the Dual Core of “Safety + Compliance”

Customized Solution: Medical-Grade Upgrading from Materials to Systems

• Sterile Material Design: Oxygen-contacting pipelines are made of medical-grade 316L stainless steel, with inner walls treated by electrolytic polishing to achieve a roughness of ≤ 0.4μm, preventing bacterial growth; equipped with medical-grade sterilizing filters with a filtration accuracy of 0.01μm, ensuring no microbial contamination in the output oxygen.

• Core Technology Adaptation: Equipped with independently developed medical low-noise molecular sieve modules, the operating noise is ≤ 45dB, meeting the noise standards for hospital wards; adopting a dual-tower alternating adsorption + intelligent pressure control system, the oxygen purity is stably maintained at 93.5%-94.2% with a pressure fluctuation of ≤ ±0.01MPa, which is compatible with different medical equipment such as ventilators and oxygen masks.

• Full Compliance Closed Loop: Cooperated with German institutions to complete the full-process testing for CE-MDR certification, including 12 rigorous tests such as electromagnetic compatibility (EMC) and biocompatibility; simultaneously issued EU-recognized medical device registration certificates, Technical Documentation (TDR), and sterility test reports, removing obstacles for customs clearance and hospital access.

Full-Chain Guarantee: The “Precision Shipment Closed Loop” for Medical Equipment

Before Delivery: Multi-Dimensional Testing to Fortify the Safety Line

1. Performance Limit Test: Under the environment of simulated European power grid fluctuations (±10% voltage change), the equipment operated at full load continuously for 72 hours, with no fluctuations in oxygen purity and flow. The emergency battery started automatically after a power failure, providing continuous oxygen supply for 4.5 hours, exceeding the customer’s requirement by 12.5%;

1. Sterility Verification: A third-party medical testing institution sampled the oxygen outlet, showing that the total number of bacterial colonies was < 1CFU/m³, meeting the sterility standards of the European Pharmacopoeia;

1. Labeling Standard Verification: The equipment body, instruction manual, and packaging are all marked with CE-MDR certification marks, UDI (Unique Device Identification) codes, and multilingual operation guidelines, fully complying with the labeling requirements for EU medical equipment.

Cross-Border Transportation: Medical-Grade Protection Adapting to Complex Routes

• Customized Packaging: Adopting a three-layer protection scheme of “sterile film sealing + EPE foam + anti-static wooden cases”; temperature and humidity sensors are built into the wooden cases to monitor the transportation environment in real-time (temperature: 0-40℃, humidity: ≤ 60%);

• Temperature-Controlled Transportation: Temperature-controlled containers are used throughout the entire journey to prevent moisture and aging of internal components of the equipment caused by extreme weather;

• Pre-Customs Clearance: 16 sets of documents including CE-MDR certification, UDI codes, and certificates of origin were submitted to German customs for pre-approval in advance, ensuring that the equipment can complete customs clearance within 48 hours after arriving at the port.

In addition to PSA Oxygen Generators, we also produce VPSA Oxygen Generators, storage tanks, heat exchangers and other products. If you are interested in VPSA Oxygen Systems or other products, please feel free to send an email to [email protected]. We will be very happy to serve you.