Singapore HSA registration DE0504893

On-X Prosthetic Heart Valve and Instruments

Singapore·CLASS D·On-X Life Technologies Inc·Registered September 08, 2020

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 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.

Product Owner

Name: On-X Life Technologies Inc
Short Name: On-X Life Technologies Inc
Address: 1300 East Anderson Lane, Building B, Austin, Texas 78752, UNITED STATES

Registrant

Name: Cryolife Asia Pacific Pte Ltd
Address: 1 MARINA BOULEVARD, ONE MARINA BOULEVARD, #28-00, SINGAPORE 018989

Importer

Name: ALCARE PHARMACEUTICALS PTE LTD
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

About this record

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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