Merit SCOUT Surgical Guidance System - HSA Registration DE0505959
Access comprehensive regulatory information for Merit SCOUT Surgical Guidance System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505959 and owned by Merit Medical Systems, Inc.. The device was registered on July 02, 2021.
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.
The SCOUT Reflector is intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SCOUT System) the SCOUT Reflector is located and surgically removed with the target tissue. The SCOUT System is intended only for the non-imaging detection and localization of the SCOUT Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal. The SCOUT Check Console is intended to be used to confirm detection of the SCOUT Reflector subsequent to percutaneous placement in Radiology.