Internationally Accredited Surgical Device Manufacturing
Universal Sutures (Unisur Lifecare Pvt. Ltd.) maintains an audited quality management framework ensuring complete technical file compliance, batch traceability, and safety parameters meeting or exceeding USP & EP standards.
EU MDR Certified
Recognized as the second medical device manufacturer in India to secure EU MDR certification, covering 13 comprehensive surgical suture and wound closure device families.
ISO 13485 System
Certified Quality Management System governing design, cleanroom production, needling, EO sterilization cycles, and final release testing of medical devices.
CE Mark Approvals
CE marked sterile absorbable and non-absorbable surgical sutures, hernia repair mesh, bone wax, and surgical accessories for international sales.
Quality Assurance & Regulatory Dossier Support for Importers
Every manufactured product lot undergoes rigorous batch testing in our Bengaluru cleanroom laboratories. Certificates of Analysis (CoA) cover needle-attachment pull test strength, tensile load capacity (minimum 1.1× USP threshold), ethylene oxide residual analysis, and bacterial endotoxin limits (LAL test). We provide complete technical files and STED documentation for fast regulatory registration in your destination market.
Verified Quality & Manufacturing Licenses
Review our official product family certifications, WHO-GMP approvals, and manufacturing licenses required for tender submissions and hospital distribution contracts.
| Certificate / License Description | Standard / Regulatory Body | Compliance Scope | Status |
|---|---|---|---|
| EU MDR Certificate | Regulation (EU) 2017/745 | 13 Product Families — Surgical Sutures & Devices | Certified |
| EN ISO 13485:2016 Certificate | ISO / BSI Quality Management | Full Medical Device Manufacturing & Quality System | Certified |
| Sterile Absorbable Sutures (CE Certificate) | CE Marking Scheme | PGA, PGLA 910, PDS, Poliglecaprone-25, Catgut | Certified |
| Sterile Non-Absorbable Sutures (CE Certificate) | CE Marking Scheme | Polypropylene, Nylon, Polyester, Silk, UHMWPE | Certified |
| Monofilament Polypropylene Mesh (CE Certificate) | CE Marking Scheme | Hernia Repair & Tissue Reinforcement Mesh | Certified |
| WHO-GMP Certificate | Good Manufacturing Practice | Cleanroom Facilities & Environmental Monitoring | Compliant |
| Laparoscopic Products Manufacturing License | CDSCO / Regulatory License | Endo Cutters, Trocars & Minimally Invasive Devices | Licensed |
| Barbed Sutures Manufacturing License | CDSCO / Licensing Authority | Knotless Polydioxanone Barbed Closure Sutures | Licensed |
| Skin Stapler & Remover License | CDSCO / Licensing Authority | Disposable Surgical Skin Staplers & Extractors | Licensed |
| UHMWPE & Specialty Suture License | CDSCO / Licensing Authority | High-Strength Polyethylene & Orthopaedic Sutures | Licensed |
| PTFE Suture Manufacturing License | CDSCO / Licensing Authority | Polytetrafluoroethylene Monofilament Sutures | Licensed |
| MD 9 Sale & Distribution License | Medical Device Licensing | Global Logistics & Wholesale Supply Compliance | Approved |