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Singapore HSA registration DE0504583

Merit Medical SuperHeRO Venous Outflow and Adapter Component Kit

Singapore flagSingapore·CLASS D·MERIT MEDICAL SYSTEMS INC·Registered June 10, 2020
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0504583
Registration Date
June 10, 2020
Change Notification Approval Date
July 29, 2024
Retention Due Date
June 09, 2025
Product description
The SuperHeRO Graft is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts.The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options.
Product Owner
Name
MERIT MEDICAL SYSTEMS INC
Short Name
MERIT MEDICAL SYSTEMS INC
Address
1600 WEST MERIT PARKWAY, SOUTH JORDAN, UTAH 84095, UNITED STATES
Registrant
Name
MERIT MEDICAL SINGAPORE PTE. LTD.
Address
198 YISHUN AVENUE 7, SINGAPORE 768926
Importer
Name
MERIT MEDICAL SINGAPORE PTE. LTD. SingMed Healthcare Systems
Address
198 YISHUN AVENUE 7, SINGAPORE 768926 10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Model information
Model Name(s)
SUPER HeRO Venous Outflow and Adapter Component Kit SUPER HeRO Venous Outflow and Adapter Component Kit
Model Identifier(s)
SUPERHERO SuperHero
About this record

Access comprehensive regulatory information for Merit Medical SuperHeRO Venous Outflow and Adapter Component Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0504583 and owned by MERIT MEDICAL SYSTEMS INC. The device was registered on June 10, 2020.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D