Singapore HSA registration DE0510414
BioGend Therapeutics RevoCart One–Step Autologous Cartilage Repair System
Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0510414
- Registration Date
- March 03, 2025
- Retention Due Date
- March 02, 2026
Product 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.
Product Owner
- Short Name
- BioGend Therapeutics Co., Ltd.
- Address
- 4F, No. 3-2, Park St, Nangang Dist, Taipei City, 11503, TAIWAN
Registrant
- Address
- 111 NORTH BRIDGE ROAD, PENINSULA PLAZA, #21-01, SINGAPORE 179098
Model information
- Model Name(s)
- (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(s)
- 2AC001 2BP001M 3BP001M 3HB001 3LB001 3RC002M 3SI001
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D