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Merit Medical Bearing nsPVA Embolization Particles - HSA Registration DE0508483

Access comprehensive regulatory information for Merit Medical Bearing nsPVA Embolization Particles in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508483 and owned by MERIT MEDICAL SYSTEMS INC. The device was registered on September 13, 2023.

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 C
DE0508483
Merit Medical Bearing nsPVA Embolization Particles
HSA Registration Number: DE0508483
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Product Description

It is used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0508483
Registration Date
September 13, 2023
Change Notification Approval Date
November 21, 2024
Retention Due Date
September 12, 2025
Product Owner
Short Name
MERIT MEDICAL SYSTEMS INC
Address
1600 WEST MERIT PARKWAY, SOUTH JORDAN, UTAH 84095, UNITED STATES
Registrant
Address
198 YISHUN AVENUE 7, SINGAPORE 768926
Importer
Address
198 YISHUN AVENUE 7, SINGAPORE 768926 10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Model Information
Model Name(s)
Bearing nsPVA Express Embolization Particles Bearing nsPVA Express Embolization Particles Bearing nsPVA Express Embolization Particles Bearing nsPVA Express Embolization Particles Bearing nsPVA Express Embolization Particles Bearing nsPVA Express Embolization Particles Bearing nsPVA Express Embolization Particles Bearing nsPVA Embolization Particles Bearing nsPVA Embolization Particles Bearing nsPVA Embolization Particles Bearing nsPVA Embolization Particles Bearing nsPVA Embolization Particles Bearing nsPVA Embolization Particles Bearing nsPVA Embolization Particles
Model Identifier(s)
S100EP S1100EP S200EP S300EP S400EP S600EP S800EP V100EP V1100EP V200EP V300EP V400EP V600EP V800EP