ComfortGel Blue / ProFile Lite Family - EUDAMED Registration 00606959020832

Access comprehensive regulatory information for ComfortGel Blue / ProFile Lite Family in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 00606959020832 and manufactured by Respironics Inc. in United States.

This page provides complete registration details including trade name (ComfortGel Blue Mask w/SE, w/Headgear, Petite, INTL), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.