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Merit Medical Implantation System for Peritoneal Dialysis Catheter - HSA Registration DE0502233

Access comprehensive regulatory information for Merit Medical Implantation System for Peritoneal Dialysis Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502233 and owned by Merit Medical Systems, Inc.. The device was registered on October 04, 2018.

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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CLASS B
DE0502233
Merit Medical Implantation System for Peritoneal Dialysis Catheter
HSA Registration Number: DE0502233
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Product Description

The Y‐TEC Implantation System can be used to implant a peritoneal dialysis catheter in patients who are suitable candidates for peritoneal dialysis therapy.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0502233
Registration Date
October 04, 2018
Change Notification Approval Date
August 12, 2024
Retention Due Date
October 03, 2025
Product Owner
Short Name
Merit Medical Systems, Inc.
Address
1600 West Merit Parkway, South Jordan, 84095, Utah, UNITED STATES
Registrant
Address
198 YISHUN AVENUE 7, SINGAPORE 768926
Importer
Address
150 BEACH ROAD, GATEWAY WEST, #30-01/08, SINGAPORE 189720 2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Model Information
Model Name(s)
Implantation System for Peritoneal Dialysis Catheter
Model Identifier(s)
VP-211