BioGend Therapeutics RevoCart One–Step Autologous Cartilage Repair System
- 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
- Risk class
- Class D
- Product owner
- BioGend Therapeutics Co., Ltd.
- Registrant / registration holder
- QUALTECH CONSULTING CORPORATION PTE. LTD.
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.
- 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
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.