Pure Global
Singapore HSA registration DE0510280

Covidien Endoflip™ 300 platform

Singapore flagSingapore·CLASS B·Covidien IIc·Registered January 24, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0510280
Registration Date
January 24, 2025
Retention Due Date
January 23, 2026
Product description
The Endoflip 300 system is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esophagus, in patients from five years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders. The Esoflip ES-310 balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy. The Esoflip ES-320 balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy. The Esoflip ES-330 Balloon Dilation Catheter is indicated for use in a clinical setting for dilating the gastroesophageal junction of a patient with Achalasia.
Product Owner
Name
Covidien IIc
Short Name
Covidien IIc
Address
15 Hampshire Street,, Mansfield, MA02048, UNITED STATES
Registrant
Name
COVIDIEN PRIVATE LIMITED
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Name
COVIDIEN PRIVATE LIMITED
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
Model Name(s)
Endoflip™ 300 Pump System Endoflip™ 300 Display System Endoflip™ 300 Reader Endoflip™ Endolumenal Functional Lumen Imaging Probe Endoflip™ Endolumenal Functional Lumen Imaging Probe Esoflip™ Endolumenal Functional Lumen Imaging Probe Esoflip™ Endolumenal Functional Lumen Imaging Probe Esoflip™ Endolumenal Functional Lumen Imaging Probe
Model Identifier(s)
EF-301 EF-302 EF-304 EF-322N EF-325N ES-310 ES-320 ES-330
About this record

Access comprehensive regulatory information for Covidien Endoflip™ 300 platform in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510280 and owned by Covidien IIc. The device was registered on January 24, 2025.

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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