Apollo Endosurgery BIB™ System Intragastric Balloon - HSA Registration DE0005149
Access comprehensive regulatory information for Apollo Endosurgery BIB™ System Intragastric Balloon in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0005149 and owned by Apollo Endosurgery, Inc.. The device was registered on June 22, 2010.
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 BIB System is indicated for obese adult (18 years or older) for: • Pre-surgical temporary use for weight loss in obese patients (BMI 40 and above or a BMI of 35 or above with comorbidities) prior to obesity or other surgery, in order to reduce surgical risk. • Temporary use for weight loss in obese patients (BMI 30-39) who have significant health risks related to their obesity and who have failed to achieve and maintain weight loss with a supervised weight-control program. The BIB System is to be used in conjunction with a long- term supervised diet and behavior modification program designed to increase the possibility of long-term weight- loss maintenance.• Temporary use for weight loss in obese patients (BMI 40 or above, or BMI 35 or above with comorbidities) who are not candidates for obesity surgery, in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight-loss maintenance.