Oxygen concentrators

Form: Portable oxygen concentrators, Stationary/Home oxygen concentrators, Transportable units

Strength: Portable units producing 1-5 L/min; stationary units up to 10-15 L/min

Reference Brands: Philips Respironics, Invacare, Inogen, AirSep, Respironics

Category: Medical Devices

Oxygen concentrators sold in the EU and US require regulatory approval to ensure safety, efficacy, and quality. In the US, FDA clearance involves clinical validation and compliance with ANSI/AAMI standards. In the EU, CE marking certifies conformity with In Vitro Diagnostic Regulations (IVDR). Devices undergo validation, stability testing, and thorough audits, with dossiers including safety profiles, performance data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, reliable oxygen therapy devices, vital for patient care, emergency services, and home respiratory support worldwide.