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Singapore HSA registration DE0505959

Merit SCOUT Surgical Guidance System

Singapore flagSingapore·CLASS C·Merit Medical Systems, Inc.·Registered July 02, 2021
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0505959
Registration Date
July 02, 2021
Change Notification Approval Date
March 25, 2024
Retention Due Date
July 01, 2025
Product description
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.
Product Owner
Name
Merit Medical Systems, Inc.
Short Name
Merit Medical Systems, Inc.
Address
6 Journey, Suite 125, Aliso Viejo, CA, 92656, UNITED STATES
Registrant
Name
MERIT MEDICAL SINGAPORE PTE. LTD.
Address
198 YISHUN AVENUE 7, SINGAPORE 768926
Importer
Name
DCH AURIGA SINGAPORE MERIT MEDICAL SINGAPORE PTE. LTD. SingMed Healthcare Systems ULTRARAY IMAGING PTE LTD
Address
10 RAEBURN PARK, #01-33, SINGAPORE 088702 198 YISHUN AVENUE 7, SINGAPORE 768926 10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564 28 SIN MING LANE, MIDVIEW CITY, #02-143, SINGAPORE 573972
Model information
Model Name(s)
SCOUTCHECK CONSOLE SCOUTCHECK CONSOLE (LOANED EQUIPMENT) SCOUT CHECK Handpiece SCOUT Single-Use Handpiece SCOUT GUIDE SCOUT GUIDE SCOUT CONSOLE SCOUT CONSOLE (LOANED EQUIPMENT) SCOUT Reflector SCOUT Reflector SCOUT Reflector SCOUT Reflector
Model Identifier(s)
CHK-01 CHK-01L CHKHP-01 HPSU-01 SG-01 SG-02 SSC-01 SSC-01L SSR05-01 SSR10-01 SSR75-01 SSR75S-01
About this record

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.

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