Digital & Infrared Thermometers

Form: Digital (oral, axillary, or rectal thermometers) and Infrared (IR) thermometers (forehead, ear, and touchless)

Strength: Clinical accuracy, rapid readings

Reference Brands: Braun ThermoScan (ear), Exergen, Kinsa

Category: Medical Devices

Digital and infrared thermometers are approved in both the US and EU, supported by dossiers demonstrating safety, accuracy, and manufacturing quality in compliance with GMP and IVDR standards. In the US, FDA approval involves clinical validation and safety assessments; in the EU, CE marking certifies conformity with in vitro diagnostic regulations. Devices undergo validation, stability testing, and audits, with 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, safe thermometry solutions for healthcare, home use, and clinical settings worldwide, supporting effective health monitoring and disease management.