Regulatory and Quality Findings

Regulatory Licenses/Clearances

The CRH O’Regan Disposable Hemorrhoid Ligator and the CRH O’Regan Disposable Anoscope have approval/clearance to be sold in Canada, the United States and the European Union. 

• For Canada, CRH Medical Products Corporation has received Medical Device Licenses 65043 and 65042 for the CRH O’Regan Disposable Hemorrhoid Ligator and CRH O’Regan Disposable Anoscope, respectively.

• In the United States, 510(k) clearance has been received for the CRH O’Regan Disposable Hemorrhoid Ligator (K963166) and the CRH O’Regan Disposable Anoscope (K020702).

• The CRH O’Regan Disposable Hemorrhoid Ligator and the CRH O’Regan Disposable Anoscope are CE Marked in Europe as Class I medical devices.

Quality System

CRH Medical Products Corporation has been certified to the ISO13485:2003 quality system standard for the design and manufacturing of its hemorrhoid banding system.