ISO 13485:2016 Certificate
Internationally recognized quality management certification specifying comprehensive requirements for medical device design, production, and distribution.
Trustworthy Quality Assurance
Exceeding International Medical Device Standards
At Uteshiya Medicare, patient safety and surgical precision drive every aspect of our manufacturing framework. As a leading manufacturer and global exporter of orthopedic trauma implants, spinal systems, and surgical instruments, our state-of-the-art facility operates under strict Quality Management Systems (QMS). From raw material verification to Class 10,000 sterile packaging, our certified product portfolio adheres to rigorous international regulatory criteria, ensuring absolute reliability for hospital procurement teams and orthopedic surgeons worldwide.
CDSCO Manufacturing License
Official authorization from the Central Drugs Standard Control Organisation (CDSCO) approving our manufacturing unit for 1,000+ certified orthopedic implants.
Free Sale Certificate (FSC)
Regulatory certification granting unrestricted commercial sale and international export capability for healthcare distributors across global markets.
FDA Registration Certificate 2026
Annual facility registration compliance documenting adherence to US FDA medical device manufacturing protocols and international safety regulations.
ZED GOLD Certificate
Highest tier national manufacturing award representing 'Zero Defect, Zero Effect' quality control, lean production processes, and environmental responsibility.
Manufacturing License Endorsement
Official regulatory endorsement expanding approved medical implant categories including titanium trauma plates, pedicle screws, and joint prostheses.
Key Quality Control Pillars at Uteshiya Medicare
Biocompatible Grade Materials
We exclusively utilize certified 316L Stainless Steel and Ti-6Al-4V ELI Titanium alloy compliant with ISO 5832 specifications for maximum biomechanical compatibility.
100% In-House Cleanroom Sterilization
Validated Class 10,000 (ISO Class 7) cleanroom environments prevent contamination, offering sterile packaging ready for immediate operative use.
Complete Batch Traceability
Every single implant unit carries unique batch code identification, facilitating full raw material and manufacturing process traceability for hospital audits.
Require Official Certification Dossiers or Technical Registration Files?
Our dedicated regulatory affairs team provides complete registration support, Free Sale documentation, and CE/FDA technical dossiers for international medical device procurement.