Hunan Endovascular Device Co., Ltd.
EVT Medical - Innovating Minimally Invasive Therapies Hunan Endovascular Device Co., Ltd. (EVT Medical), a subsidiary of APT Medical Group (Mindray Network), specializes in non-vascular interventional devices for urology, GI, gynecology, and respiratory care. With 13+ years of expertise, we deliver high-quality, NMPA/CE-certified solutions to 90+ countries, driven by R&D; and vertical integration. Mission: Advancing global healthcare through minimally invasive, clinically proven technologies. |
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Company Name: Hunan Endovascular Device Co., Ltd. Business Type: Manufacturer Brands: EVT Employee Number: 200~500 Factory Location: Building C7, Huanchuang Enterprise Plaza, High-tech Zone, Changsha City, Hunan Province, China - Trade & Market
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Company slogan: Hunan Endovascular Device Co., Ltd. （EVT Medical） OEM Overview: For OEM partners- Turnkey production from blueprints to packaged devices
- Flexible batches (50pcs trial runs to mass production)
For ODM collaborations- 50+ urology device platforms for customization
- Shared IP options for co-developed products
Production Line: Smart Production LineOur 1,800m ² smart factory integrates:
- Robotic assembly : 6-axis precision arms for consistent device assembly
- Automated inspection : AI-powered visual detection (0.01mm accuracy)
- Sterilization center : 100m³ EO capacity with full ISO 11135 compliance
Key advantage: 40% higher efficiency vs traditional lines
About quality management: Quality Assurance & Regulatory ComplianceManufacturing Excellence- Full vertical integration ensures end-to-end quality control from raw materials to finished devices
- ISO 13485:2016 certified by TÜV SÜD (quality management system)
- CE-MDR (2017/745) upgrade underway (anticipated Q1 2025) with TÜV SÜD as notified body
- 24 products approved under China NMPA medical device registration
Clinical Validation- 15+ years of specialized nephrostomy device manufacturing expertise
- 12 clinical studies demonstrating safety and efficacy (data available upon request)
- Documented 98.2% first-attempt success rate across 2,300+ PCNL procedures
Continuous Quality Commitment- Quarterly ISO 10993 biocompatibility testing protocol
- 100% real-time needle sharpness verification during production
- Dedicated MDR transition team implementing enhanced post-market surveillance
Competitive Advantages- Single-source manufacturing ensures supply chain security
- Dual regulatory compliance (24 NMPA approvals + ISO 13485)
- Active FDA 510(k) preparation for Q2 2025 submission
Services: With 32% R &D staff, we master:- Material science : Hydrophilic coatings, metal-polymer hybrids
- Precision engineering : Laser cutting/welding, tip forming
- Process innovation : Multi-metal welding, braided catheter tech
Our Team: Our Team: Expertise Driving Innovation1. Elite Marketing ForceWe maintain a highly-skilled, professional marketing team with deep industry insights and customer-centric approaches. Their expertise ensures rapid market penetration and tailored solutions for global clients.
2. Rigorous Quality AssuranceOur certified inspectors enforce stringent quality control throughout production, guaranteeing full compliance with ISO 13485, CE, and FDA standards - from raw materials to finished products.
3. Advanced R &D CapabilityWith 32% of workforce dedicated to R &D, our engineers specialize in biomaterials, precision manufacturing, and medical device innovation. The team holds 10+ patents and collaborates with leading medical institutions to pioneer cutting-edge solutions.
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Market name: South America,Eastern Asia,Southeast Asia,Middle East,Africa,Oceania Contact Person: Mr.David Contact Phone: 86--18390980188