Singapore HSA registration DE0508390
Abbott Regent Mechanical Heart Valve Sizer Set
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0508390
- Registration Date
- August 16, 2023
- Change Notification Approval Date
- December 22, 2023
- Retention Due Date
- August 15, 2025
Product description
The Regent Mechanical Heart Valve Sizer Set Model 907 is a kit comprised of multiple sizing tools that facilitate proper handling and implant size selection of the Regent Mechanical 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)
- Valve Holder Handle Regent Mechanical Heart Valve Sizer Set
- Model Identifier(s)
- 905-HH 907
About this record
Access comprehensive regulatory information for Abbott Regent Mechanical Heart Valve Sizer Set in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508390 and owned by Abbott Medical. The device was registered on August 16, 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 DatabasePowered by Pure Global AIHSA Official DataCLASS B