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Singapore HSA registration DE0505671

Merit Medical PreludeEASE™ Hydrophilic Sheath Introducer

Singapore flagSingapore·CLASS B·Merit Medical Systems, Inc.·Registered April 19, 2021
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0505671
Registration Date
April 19, 2021
Retention Due Date
April 18, 2026
Product description
The Merit PreludeEASE™ Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires.
Product Owner
Name
Merit Medical Systems, Inc.
Short Name
Merit Medical Systems, Inc.
Address
1600 West Merit Parkway, South Jordan, Utah, 84095, Utah, 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)
PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer PreludeEASE™ HYDROPHILIC Sheath Introducer
Model Identifier(s)
PHR4F11018NTPD PHR4F11018SC PHR4F11018SS PHR4F11018SSSN PHR4F11021PW PHR4F11021SC PHR4F11021SCSN PHR4F11025PW PHR4F16018NT PHR4F16021SC PHR4F16025PW PHR4F23018NT PHR4F23021PW PHR4F23021SC PHR4F7018NTPD PHR4F7018SC PHR5F11018NTPD PHR5F11018SC PHR5F11018SS PHR5F11018SSSN PHR5F11021PW PHR5F11021SC PHR5F11021SCSN PHR5F11021SSC PHR5F11025PW PHR5F16018NT PHR5F16021SC PHR5F16025PW PHR5F23018NT PHR5F23021PW PHR5F23021SC PHR5F23021SSC PHR5F7018NTPD PHR5F7018SC PHR6F11018NTPD PHR6F11018SC PHR6F11018SS PHR6F11018SSSN PHR6F11021PW PHR6F11021SC PHR6F11021SCSN PHR6F11021SSC PHR6F11025PW PHR6F11035SC PHR6F16018NT PHR6F16021SC PHR6F16025PW PHR6F23018NT PHR6F23021PW PHR6F23021SC PHR6F23021SSC PHR6F7018NTPD PHR6F7018SC PHR7F11018SC PHR7F11021SC PHR7F11035SC PHR7F16018NT PHR7F16021SC PHR7F23018NT PHR7F23021SC
About this record

Access comprehensive regulatory information for Merit Medical PreludeEASE™ Hydrophilic 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 DE0505671 and owned by Merit Medical Systems, Inc.. The device was registered on April 19, 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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