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HSA · registration DE0510414

BioGend Therapeutics RevoCart One–Step Autologous Cartilage Repair System

SingaporeOrthopaedicsClass DBioGend Therapeutics Co., Ltd.
Official record identity
Registration number
DE0510414
Model name
(AccuCut Cartilage Processor); (Chondroplug Bioresorbable Scaffold Implant); RevoCart One–Step Autologous Cartilage Repair System (Chondroplug); Revocart Buffer Solution; Revocart Enzyme; RevoCart One–Step Autologous Cartilage Repair System; BioGend surgical instrument kits
Model identifier
2AC001; 2BP001M; 3BP001M; 3HB001; 3LB001; 3RC002M; 3SI001
Registration date
March 03, 2025
Classification
Risk class
Class D
Official value: CLASS D
Published category
Orthopaedics
Published parties
Registrant / registration holder
QUALTECH CONSULTING CORPORATION PTE. LTD.
Official description

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.

Additional source fields
Product owner address
4F, No. 3-2, Park St, Nangang Dist, Taipei City, 11503, Taiwan
Registrant address
111 NORTH BRIDGE ROAD, #21-01, PENINSULA PLAZA, Singapore 179098
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.