Singapore HSA registration DE0005146
Apollo Endosurgery ORBERA365™ Intragastric Balloon System
Singapore·CLASS C·Apollo Endosurgery, Inc.·Registered June 22, 2010Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0005146
- Registration Date
- June 22, 2010
- Change Notification Approval Date
- April 02, 2025
- Retention Due Date
- August 09, 2025
Product description
The ORBERA365 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. The ORBERA365 System is indicated for: • Temporary use for weight loss in obese patients (BMI 30-50) who failed to achieve and maintain weight loss with a supervised weight-control program. • Pre-surgical temporary use for weight loss in obese and super obese patients (BMI 40 and above or a BMI of 35 with comorbidities) prior to obesity or other surgery, in order to reduce surgical risk. The maximum placement period for the ORBERA365™ System is 12 months, and it must be removed at that time or earlier.
Product Owner
- Short Name
- Apollo Endosurgery, Inc.
- Address
- 1120 S Capital of Texas Hwy, Building 1, Suite 300, Austin, TX 78746, UNITED STATES
Registrant
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588 37 UBI CRESCENT, SINGAPORE 408586
Model information
- Model Name(s)
- ORBERA365™ Intragastric Balloon System
- Model Identifier(s)
- B-50012
About this record
Access comprehensive regulatory information for Apollo Endosurgery ORBERA365™ Intragastric 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 DE0005146 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.
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