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Singapore HSA registration DE0506553

On-X On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft

Singapore flagSingapore·CLASS D·On-X Life Technologies Inc·Registered January 03, 2022
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0506553
Registration Date
January 03, 2022
Retention Due Date
January 02, 2026
Product description
The On-X Ascending Aortic Prosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.
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 Ascending Aortic Prosthesis with Vascutek Gelweave Valsalva Graft On-X Ascending Aortic Prosthesis with Vascutek Gelweave Valsalva Graft On-X Ascending Aortic Prosthesis with Vascutek Gelweave Valsalva Graft On-X Ascending Aortic Prosthesis with Vascutek Gelweave Valsalva Graft On-X Ascending Aortic Prosthesis with Vascutek Gelweave Valsalva Graft
Model Identifier(s)
ONXAAP-19 ONXAAP-21 ONXAAP-23 ONXAAP-25 ONXAAP-27/29
About this record

Access comprehensive regulatory information for On-X On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506553 and owned by On-X Life Technologies Inc. The device was registered on January 03, 2022.

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 D