Pure Global

Abbott Medical Epic Stented Tissue Valve - HSA Registration DE0508589

Access comprehensive regulatory information for Abbott Medical Epic Stented Tissue Valve in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0508589 and owned by Abbott Medical. The device was registered on October 20, 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS D
DE0508589
Abbott Medical Epic Stented Tissue Valve
HSA Registration Number: DE0508589
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Epic Plus valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve. The Epic Plus Supra valve and Epic Max valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0508589
Registration Date
October 20, 2023
Change Notification Approval Date
May 05, 2025
Retention Due Date
October 19, 2025
Product Owner
Short Name
Abbott Medical
Address
177 County Road B East, St. Paul, Minnesota 55117, UNITED STATES
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model Information
Model Name(s)
Epic Plus Stented Tissue Valve Epic Plus Stented Tissue Valve Epic Plus Stented Tissue Valve Epic Plus Stented Tissue Valve Epic Plus Stented Tissue Valve Epic Plus Stented Tissue Valve Epic Plus Stented Tissue Valve Epic Plus Stented Tissue Valve Epic Plus Stented Tissue Valve Epic Plus Stented Tissue Valve Epic Plus Heart Valve Sizer Set Holder Handle, Model E2000-HA Holder Handle, Model E2000-HM Epic Max Heart Valve Sizer Set Epic Max Stented Tissue Valve Epic Max Stented Tissue Valve Epic Max Stented Tissue Valve Epic Max Stented Tissue Valve Epic Max Stented Tissue Valve Epic Plus Supra Stented Tissue Valve Epic Plus Supra Stented Tissue Valve Epic Plus Supra Stented Tissue Valve Epic Plus Supra Stented Tissue Valve Epic Plus Supra Stented Tissue Valve
Model Identifier(s)
E200-21A E200-23A E200-25A E200-25M E200-27A E200-27M E200-29A E200-29M E200-31M E200-33M E2000 E2000-HA E2000-HM EMAX-1000 EMAX-19 EMAX-21 EMAX-23 EMAX-25 EMAX-27 ESP200-19 ESP200-21 ESP200-23 ESP200-25 ESP200-27