HSA · registration DE0510280Covidien Endoflip™ 300 platform
- Registration number
- DE0510280
- Model name
- 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
- EF-301; EF-302; EF-304; EF-322N; EF-325N; ES-310; ES-320; ES-330
- Registration date
- January 24, 2025
- Risk class
- Class B
- Product owner
- Covidien IIc
- Registrant / registration holder
- COVIDIEN PRIVATE LIMITED
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 address
- 15 Hampshire Street,, Mansfield, MA02048, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.