Edwards EV1000 Clinical Platform - HSA Registration DE0011398
Access comprehensive regulatory information for Edwards EV1000 Clinical Platform in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0011398 and owned by Edwards Lifesciences LLC. The device was registered on October 22, 2012.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The EV1000 is indicated primarily for critical care patients in which the balance between oxygen delivery and consumption, cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and shape is used to determine intravascular and extravascular fluid volumes. The EV1000 platform may be used in all settings in which critical care is provided.