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Singapore HSA registration DE0503433

Merit Medical HepaSphere Microspheres

Singapore flagSingapore·CLASS C·MERIT MEDICAL SYSTEMS INC·Registered August 05, 2019
Device classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0503433
Registration Date
August 05, 2019
Change Notification Approval Date
March 25, 2024
Retention Due Date
August 04, 2025
Product description
HepaSphere™ Microspheres are intended for use in embolization of blood vessels. HepaSphere™ Microspheres are indicated for use, with or without delivery of doxorubicin HCl for therapeutic or preoperative purposes in the following procedures: • Embolization of hepatocellular carcinoma • Embolization of metastases to the liver. HepaSphere Microspheres loaded with irinotecan are indicated for use in: • Embolization of metastatic colorectal cancer (mCRC) to the liver
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
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)
HepaSphere Microspheres HepaSphere Microspheres HepaSphere Microspheres HepaSphere Microspheres HepaSphere Microspheres
Model Identifier(s)
V125HS V225HS V325HS V525HS V725HS
About this record

Access comprehensive regulatory information for Merit Medical HepaSphere Microspheres in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503433 and owned by MERIT MEDICAL SYSTEMS INC. The device was registered on August 05, 2019.

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 C