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Merit Medical EmboCube Embolization Gelatin - HSA Registration DE0508768

Access comprehensive regulatory information for Merit Medical EmboCube Embolization Gelatin in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0508768 and owned by MERIT MEDICAL SYSTEMS INC. The device was registered on December 15, 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 D
DE0508768
Merit Medical EmboCube Embolization Gelatin
HSA Registration Number: DE0508768
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Product Description

EmboCube Embolization Gelatin is intended for embolization of blood vessels to occlude blood flow for controlling bleeding / hemorrhaging. EmboCube Embolization Gelatin occludes vessels up to 5 mm. EmboCube Embolization Gelatin is intended to be used in adults.

Device Classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508768
Registration Date
December 15, 2023
Retention Due Date
December 14, 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)
Merit Medical Embocube Merit Medical Embocube Merit Medical Embocube Merit Medical Embocube Merit Medical Embocube Merit Medical Embocube
Model Identifier(s)
EC25100 EC2525 EC2550 EC50100 EC5025 EC5050