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On-X Prosthetic Heart Valve and Instruments - HSA Registration DE0504893

Access comprehensive regulatory information for On-X Prosthetic Heart Valve and Instruments in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0504893 and owned by On-X Life Technologies Inc. The device was registered on September 08, 2020.

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
DE0504893
On-X Prosthetic Heart Valve and Instruments
HSA Registration Number: DE0504893
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Product Description

The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0504893
Registration Date
September 08, 2020
Change Notification Approval Date
January 03, 2023
Retention Due Date
September 07, 2025
Product Owner
Short Name
On-X Life Technologies Inc
Address
1300 East Anderson Lane, Building B, Austin, Texas 78752, UNITED STATES
Registrant
Address
1 MARINA BOULEVARD, ONE MARINA BOULEVARD, #28-00, SINGAPORE 018989
Importer
Address
12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516
Model Information
Model Name(s)
On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Heart Valve Instruments On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve
Model Identifier(s)
ONXACE-19 ONXACE-21 ONXACE-23 ONXACE-25 ONXACE-27/29 ONXAE-19 ONXAE-21 ONXAE-23 ONXAE-25 ONXAE-27/29 ONXANE-19 ONXANE-21 ONXANE-23 ONXANE-25 ONXANE-27/29 ONXI2-19S ONXI2-21S ONXI2-23-25S ONXI2-23S ONXI2-25S ONXI2-27-29S ONXI2-27-33S ONXI2-CK ONXI3-19S ONXI3-21S ONXI3-23-25S ONXI3-23S ONXI3-25S ONXI3-27-29S ONXI3-27-33S ONXI3-CK ONXM-23 ONXM-25 ONXM-27/29 ONXM-31/33 ONXMC-25/33