Spirometers

Form: Portable handheld spirometers, Desktop (tabletop) spirometers, Wireless or connected spirometers

Strength: Accurate measurement of FVC, FEV1

Reference Brands: NDD Medical (EasyOne, Spirolab), MSerdi, Vitalograph, Care Fusion

Category: Medical Devices

Spirometers in the EU and US are regulated to ensure safety, accuracy, and performance. In the US, FDA approval requires extensive validation, clinical data, and compliance with medical device standards. In the EU, CE marking certifies conformity with in vitro diagnostic and medical device regulations. These devices undergo validation, stability testing, and quality 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 reliable, accurate pulmonary function testing essential for diagnosing respiratory conditions and improving patient outcomes worldwide.