Pure Global
Singapore HSA registration DE0504415

Merit Medical™ Merit Mini Access Kit

Singapore flagSingapore·CLASS B·MERIT MEDICAL SYSTEMS INC·Registered May 04, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0504415
Registration Date
May 04, 2020
Change Notification Approval Date
June 25, 2024
Retention Due Date
May 03, 2026
Product description
The Merit MAK/ S-MAK is intended for percutaneous placement of a 0.035" (0.89mm) guide wire into the vascular system. The Merit S-MAKXL is intended for percutaneous placement of a 0.038” (0.97mm) guidewire, laser fiber or catheter into the vascular system.
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
DCH AURIGA SINGAPORE MERIT MEDICAL SINGAPORE PTE. LTD. SOMNOTEC (S) PTE. LTD. SingMed Healthcare Systems
Address
10 RAEBURN PARK, #01-33, SINGAPORE 088702 198 YISHUN AVENUE 7, SINGAPORE 768926 37 UBI CRESCENT, SINGAPORE 408586 10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Model information
Model Name(s)
MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAKXL S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit S-MAK Mini Access Kit
Model Identifier(s)
MAK401 MAK401-E MAK401-PED MAK401N MAK401N-E MAK401N-PED MAK401NBT MAK401NEBT MAK401NPD MAK401NPD-E MAK401NPDBT MAK401NPDEBT MAK405 MAK405-E MAK405-PED MAK405PD MAK4F-10 MAK501 MAK501-E MAK501-PED MAK501N MAK501N-15 MAK501N-E MAK501N-PED MAK501NBT MAK501NEBT MAK501NPD MAK501NPD-E MAK501NPDBT MAK501NPDEBT MAK505 MAK505-E MAK505-PED MAK505PD MAK5F-10 MAK5F-15 S-MAK401 S-MAK401N S-MAK401NBT S-MAK401NPD S-MAK401NPDBT S-MAK405 S-MAK430NPD S-MAK4F-10 S-MAK501 S-MAK501N S-MAK501N-15 S-MAK501N15BT S-MAK501NBT S-MAK501NPD S-MAK501NPDBT S-MAK505 S-MAK5F-10 S-MAK5F-15
About this record

Access comprehensive regulatory information for Merit Medical™ Merit Mini Access Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504415 and owned by MERIT MEDICAL SYSTEMS INC. The device was registered on May 04, 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 B