HSA · registration DE0508390

Abbott Regent Mechanical Heart Valve Sizer Set

Name: Abbott Regent Mechanical Heart Valve Sizer Set — HSA DE0508390
Creator: Abbott Medical
Keywords: Abbott Regent Mechanical Heart Valve Sizer Set, Abbott Regent Mechanical Heart Valve Sizer Set, DE0508390, Cardiovascular, HSA

SingaporeCardiovascularClass BAbbott Medical

Verified

Official record identity

Registration number: DE0508390
Model name: Valve Holder Handle; Regent Mechanical Heart Valve Sizer Set
Model identifier: 905-HH; 907
Registration date: August 16, 2023
Source update date: December 22, 2023

Classification

Risk class: Class B
Published category: Cardiovascular

Published parties

Product owner: Abbott Medical
Registrant / registration holder: ABBOTT MEDICAL (SINGAPORE), PTE. LTD.

Official 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.

Additional source fields

Product owner address: 177 County Road B East, St. Paul, Minnesota 55117, United States
Registrant address: 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.