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Regulatory Details
The EndoFLIP® Imaging System is CE-marked and FDA approved, and is available for sale.
FDA - Affirmations of Compliance
Crospon ISO13485 Quality System Certification
EndoFLIP EF/BF-325 510k clearance
EndoFLIP Declaration of Conformity
EndoFLIP Electrical Safety Certification
EndoFLIP Australian TGA Certification
EndoFLIP Canadian Medical Device Certification
| EndoFLIP® Technology |
| Introduction |
| Technology behind EndoFLIP® |
| Regulatory Details |
| General Clinical Papers |
Crospon Ireland. Galway Business Park, Dangan, Galway, Ireland Phone: +353-91-519880