CPAP & BiPAP Machines

Form: CPAP (Continuous Positive Airway Pressure): Delivers steady pressurized air; BiPAP (Bi-level Positive Airway Pressure): Provides two pressure levels (inhale/exhale)

Strength: Wide range of pressure settings, advanced waveform options, auto-adjusting modes, personalized mask compatibility, FDA-approved for sleep apnea and respiratory therapy

Reference Brands: ResMed, Philips Respironics, DeVilbiss, Fisher & Paykel

Category: Medical Devices

CPAP and BiPAP machines are regulated in the EU and US, with dossiers demonstrating safety, efficacy, and manufacturing quality compliant with GMP and MDR standards. In the US, FDA approval requires clinical validation and safety testing, while in the EU, CE marking certifies conformity with in vitro diagnostic regulations. These devices undergo validation, stability testing, and thorough audits, with detailed documentation 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 respiratory support devices vital for treating sleep apnea and respiratory disorders worldwide.