Singapore HSA registration DE0508589
Abbott Medical Epic Stented Tissue Valve
Singapore·CLASS D·Abbott Medical·Registered October 20, 2023Device 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 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.
Product Owner
- Name
- Abbott Medical
- 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
About this record
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.
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