BioGend Therapeutics RevoCart One–Step Autologous Cartilage Repair System - HSA Registration DE0510414
Access comprehensive regulatory information for BioGend Therapeutics RevoCart One–Step Autologous Cartilage Repair System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510414 and owned by BioGend Therapeutics Co., Ltd.. The device was registered on March 03, 2025.
This page provides complete registration details including product owner information, registrant details, 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.
The RevoCart One–Step Autologous Cartilage Repair System is intended to treat symptomatic chondral and osteochondral articular lesions of the knee. Only “AccuCut Cartilage Processor is used for mincing cartilage tissue into small particulates, subsequently for partially dissociating the cartilaginous ECM of the cartilage particulates using Enzyme reconstituted with Buffer solution, followed by rinsing cartilage particulates to remove residual enzyme, and collecting cartilage particulates. The autologous cartilage particulates are then loaded into the cavity inside Chondroplug prior to implanting into articular defects of the knee. The Chondroplug Bioresorbable Scaffold Implant is a resorbable scaffold to facilitate bone tissue in growth in the treatment of symptomatic chondral and osteochondral articular lesions of the knee” have been reviewed and registered as a medical device on the Singapore Medical Device Register.