Singapore HSA registration DE0504888
Apollo Endosurgery Overtube™ Endoscopic Access System
Singapore·CLASS B·Apollo Endosurgery, Inc.·Registered September 04, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0504888
- Registration Date
- September 04, 2020
- Change Notification Approval Date
- March 17, 2025
- Retention Due Date
- September 03, 2025
Product description
The OverTube™ is intended to be used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the lower or upper gastrointestinal tract.
Product Owner
- Short Name
- Apollo Endosurgery, Inc.
- Address
- 1120 S Capital of Texas Hwy., Building 1, Suite 300, Austin, Texas 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)
- OverTube™ Endoscopic Access System
- Model Identifier(s)
- OVT-027-160
About this record
Access comprehensive regulatory information for Apollo Endosurgery Overtube™ Endoscopic Access System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504888 and owned by Apollo Endosurgery, Inc.. The device was registered on September 04, 2020.
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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