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Singapore HSA registration DE0505513

Cryolife PhotoFix® Decellularized Bovine Pericardium

Singapore flagSingapore·CLASS D·CryoLife, Inc.·Registered March 01, 2021
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0505513
Registration Date
March 01, 2021
Retention Due Date
February 28, 2026
Product description
PhotoFix is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).
Product Owner
Name
CryoLife, Inc.
Short Name
CryoLife, Inc.
Address
1655 Roberts Blvd., NW, Kennesaw, GA 30144, 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)
PhotoFix® Decellularized Bovine Pericardium PhotoFix® Decellularized Bovine Pericardium PhotoFix® Decellularized Bovine Pericardium PhotoFix® Decellularized Bovine Pericardium PhotoFix® Decellularized Bovine Pericardium PhotoFix® Decellularized Bovine Pericardium PhotoFix® Decellularized Bovine Pericardium PhotoFix® Decellularized Bovine Pericardium
Model Identifier(s)
PFP0.8X8 PFP1X10 PFP1X14 PFP1X6 PFP2X9 PFP4X4 PFP6X8 PFP8X14
About this record

Access comprehensive regulatory information for Cryolife PhotoFix® Decellularized Bovine Pericardium in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0505513 and owned by CryoLife, Inc.. The device was registered on March 01, 2021.

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