Spatz FGIA Spatz3 Adjustable Balloon System - HSA Registration DE0017178
Access comprehensive regulatory information for Spatz FGIA Spatz3 Adjustable Balloon System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0017178 and owned by SPATZ FGIA Inc.. The device was registered on May 19, 2015.
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 Spatz3 Adjustable Balloon System® is indicated for temporary use in weight-loss therapy for overweight and obese patients who have significant health risks related to their weight and have failed to achieve and maintain weight loss with a supervised weight-control program. The maximum placement period for the Spatz3 Adjustable Balloon System is 12 months, and must be removed at that time or earlier. It is indicated for : • Pre-surgical temporary use for weight loss in morbidly obese patients (BMI 40 and above or a BMI of 35 with co-morbidities) prior to bariatric or other surgery, in order to reduce surgical risk. • Temporary use for weight loss in overweight and obese patients (BMI > 27) who have failed to achieve and maintain weight-loss with a supervised weight control program. The system is to be used in conjunction with a long-term supervised diet and behaviour modification program designed to increase the possibility of long term weight-loss maintenance.