A reliable way to identify a genuine oxygen concentrator manufacturer is to look beyond the product catalog and review its factory facilities, quality-management system, certifications, manufacturing records, technical documentation, and production capacity.

Longfian has more than 20 years of experience in oxygen concentrator manufacturing and sales, operates a factory covering approximately 20,000 m², and has an annual production capacity of around 600,000 units.

For suppliers serving the U.S. market, the FDA database can also help verify whether a company is registered as a manufacturer and which medical devices are listed under its registration.

Certification and registration requirements vary by country and product model, so buyers should always confirm the requirements for their target market. Longfian operates under an ISO 13485 quality management system and holds certifications or market qualifications including CE, FDA, and MDSAP, along with FAA-related approvals for applicable portable models. Longfian has also completed medical-device registrations in more than 45 countries, with products supplied to over 120 countries worldwide.

Longfian manages product quality through an ISO 13485-based quality system, in-process QA/QC, and dedicated laboratory testing. During R&D, oxygen concentrators are tested for noise, operating time, oxygen concentration, transport impact resistance, and simulated high-altitude performance. The QA/QC team also checks product appearance and oxygen concentration, supported by equipment for acoustic testing, temperature and humidity testing, altitude simulation, and drop testing.