Pure Global

Apollo Endosurgery Overtube™ Endoscopic Access System - HSA Registration DE0504888

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0504888
Apollo Endosurgery Overtube™ Endoscopic Access System
HSA Registration Number: DE0504888
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device 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 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