Philippines FDA registration CMDR-2024-02231

Edwards Lifesciences® Inspiris™ Resilia™ Aortic Valve

Philippines·Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614-5686 USA Mfd By: Edwards Lifesciences (Singapore) Pte. Ltd. - 35 Chang North Crescent Singapore 499641·USA·Issued January 11, 2024 – January 11, 2029

Device information

Product Name: Edwards Lifesciences® Inspiris™ Resilia™ Aortic Valve
Registration Number: CMDR-2024-02231

Manufacturer details

Manufacturer: Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614-5686 USA Mfd By: Edwards Lifesciences (Singapore) Pte. Ltd. - 35 Chang North Crescent Singapore 499641
Country of Origin: USA

Importer & distribution

Importer/Distributor: RG Meditron, Inc.

Registration dates

Issuance Date: January 11, 2024
Expiry Date: January 11, 2029

About this record

Access comprehensive regulatory information for Edwards Lifesciences® Inspiris™ Resilia™ Aortic Valve in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number CMDR-2024-02231 and manufactured by Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614-5686 USA Mfd By: Edwards Lifesciences (Singapore) Pte. Ltd. - 35 Chang North Crescent Singapore 499641 in USA. The device was registered on January 11, 2024.

This page provides complete registration details including manufacturer information, importer/distributor details (RG Meditron, Inc.), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.