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Singapore HSA registration DE0503202

Merit Medical Prelude Short Sheath Introducer

Singapore flagSingapore·CLASS B·MERIT MEDICAL SYSTEMS INC·Registered May 31, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0503202
Registration Date
May 31, 2019
Change Notification Approval Date
April 30, 2024
Retention Due Date
May 30, 2025
Product description
The Merit Prelude Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. This device is not indicated for long term vascular or hemodialysis access.
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)
Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer Merit Medical Prelude Short Sheath Introducer
Model Identifier(s)
PSS-5F-4-018MT PSS-5F-4-035MT PSS-5F-4-038MT PSS-5F-4MT PSS-6F-4-018MT PSS-6F-4-035MT PSS-6F-4-038MT PSS-6F-4MT PSS-7F-4-018MT PSS-7F-4-035MT PSS-7F-4-038MT PSS-7F-4MT PSS-8F-4-018MT PSS-8F-4-035MT PSS-8F-4-038MT PSS-8F-4MT
About this record

Access comprehensive regulatory information for Merit Medical Prelude Short Sheath Introducer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503202 and owned by MERIT MEDICAL SYSTEMS INC. The device was registered on May 31, 2019.

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 B