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Singapore HSA registration DE0505359

Merit Medical Merit Angioplasty Pack

Singapore flagSingapore·CLASS B·Merit Medical Systems, Inc.·Registered January 19, 2021
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0505359
Registration Date
January 19, 2021
Change Notification Approval Date
July 04, 2024
Retention Due Date
January 18, 2026
Product description
Merit Medical angioplasty packs contain haemostasis valves recommended for maintaining a fluid tight seal around percutaneous transluminal angioplasty catheters and guidewires.
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)
Merit Angioplasty Pack™ FLO40XR™ Hemostasis Valve Merit Angioplasty Pack™ FLO40XR™ Hemostasis Valve Merit Angioplasty Pack™ FLO40XR™ Hemostasis Valve Merit Angioplasty Pack™ FLO40XR™ Hemostasis Valve Merit Angioplasty Pack™ FLO40XR™ Hemostasis Valve Merit Angioplasty Pack™ Passage® Hemostasis Valve Merit Angioplasty Pack™ Passage® Hemostasis Valve Merit Angioplasty Pack™ Passage® Hemostasis Valve Merit Angioplasty Pack™ Access-9™ Hemostasis Valve Merit Angioplasty Pack™ Access-9™ Hemostasis Valve Merit Angioplasty Pack™ Access-9™ Hemostasis Valve Merit Angioplasty Pack™ AccessPLUS™ Hemostasis Valve Merit Angioplasty Pack™ AccessPLUS™ Hemostasis Valve Merit Angioplasty Pack™ AccessPLUS™ Hemostasis Valve Merit Angioplasty Pack™ AccessPLUS™ Hemostasis Valve Merit Angioplasty Pack™ AccessPLUS™ Hemostasis Valve Merit Angioplasty Pack™ AccessPLUS™ Hemostasis Valve Merit Angioplasty Pack™ DoublePlay™ Hemostasis Valve Merit Angioplasty Pack™ DoublePlay™ Hemostasis Valve Merit Angioplasty Pack™ DoublePlay™ Hemostasis Valve Merit Angioplasty Pack™ Honor® Hemostasis Valve Merit Angioplasty Pack™ Honor® Hemostasis Valve Merit Angioplasty Pack™ Honor® Hemostasis Valve Merit Angioplasty Pack™ Honor® Hemostasis Valve Merit Angioplasty Pack™ Honor® Hemostasis Valve Merit Angioplasty Pack™ Honor® Hemostasis Valve Merit Angioplasty Pack™ Honor® Hemostasis Valve Merit Angioplasty Pack™ Honor® Hemostasis Valve Merit Angioplasty Pack™ MBA™ Hemostasis Valve Merit Angioplasty Pack™ MBA™ Hemostasis Valve Merit Angioplasty Pack™ MBA™ Hemostasis Valve Merit Angioplasty Pack™ MBA™ Hemostasis Valve Merit Angioplasty Pack™ MBAplus™ Hemostasis Valve Merit Angioplasty Pack™ MBAplus™ Hemostasis Valve Merit Angioplasty Pack™ PhD™ Hemostasis Valve Merit Angioplasty Pack™ PhD™ Hemostasis Valve Merit Angioplasty Pack™ PhD™ Hemostasis Valve Merit Angioplasty Pack™ PhD™ Hemostasis Valve Merit Angioplasty Pack™ PhD™ Hemostasis Valve Merit Angioplasty Pack™ FLO50™ Hemostasis Valve Merit Angioplasty Pack™ FLO50™ Hemostasis Valve
Model Identifier(s)
FLO40XR FLO40XR51 FLO40XR52 FLO40XR53 FLO40XR54 MAP101 MAP102 MAP104 MAP111 MAP112 MAP113 MAP150 MAP151 MAP152 MAP152SD MAP153 MAP154 MAP220 MAP221 MAP222 MAP300 MAP301 MAP302 MAP350 MAP351 MAP352 MAP353 MAP354 MAP400 MAP403 MAP450 MAP453 MAP464 MAP466 MAP800 MAP801 MAP802 MAP803 MAP804 MAP900 MAP952
About this record

Access comprehensive regulatory information for Merit Medical Merit Angioplasty Pack in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505359 and owned by Merit Medical Systems, Inc.. The device was registered on January 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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