Ease Medical Apparatus And Instruments
Ease Medical Apparatus And Instruments
Vertebroplasty has evolved from a niche radiological procedure to a cornerstone of modern geriatric orthopedics. As a leading CE Certified Vertebroplasty Factory & Exporter, we recognize that the global surge in osteoporotic patients demands more than just products—it requires integrated surgical solutions. Our approach focuses on the biomechanical stabilization of the spine, utilizing high-viscosity bone cements and precision delivery systems to mitigate the risk of PMMA (Polymethyl Methacrylate) leakage, a critical concern in spinal intervention.
Our systems are designed for high-pressure controlled delivery, ensuring that bone cement permeates the trabecular bone structure without extravasation into the spinal canal or venous system.
Specialized 11G and 13G biopsy needles and trocars allow for transpedicular access with minimal tissue trauma, reducing patient recovery time from weeks to mere hours.
We leverage Titanium Grade 5 (Ti-6Al-4V ELI) for our accompanying instrumentation, ensuring maximum strength and biocompatibility during the acute phase of vertebral restoration.
With over 10 years of export experience and a massive 30,343㎡ manufacturing base, we stand as a beacon of reliability in the medical device export sector.
Navigating the complex landscape of MDR (Medical Device Regulation) and MDSAP is our specialty. We provide full technical documentation (TD) and Clinical Evaluation Reports (CER) to support our global distributors in local registration processes, including SFDA, ANVISA, and TGA requirements.
Our R&D team, featuring PhD-level engineers, focuses on "Information Gain" in surgical outcomes. We don't just manufacture; we innovate on the viscosity-time curve of bone cement to give surgeons a larger "working window."
Operating 12 state-of-the-art production lines, we ensure traceability from raw material ingots to the final sterilized package. Every Vertebroplasty kit undergoes rigorous stress-testing to simulate intra-vertebral pressures.
Registration Date: 2015-10-15
Floor Space: 30,343 ㎡
Exporting Years: 10 Years
Main Markets: Domestic (80%), Eastern Europe (5%), Southeast Asia (5%)
Customization: Sample processing, graphic processing, customized on demand.
ISO13485
MDSAP
CE MDREngineers: 31 R&D Specialists (1 Doctorate, 11 Post-graduates)
Inspections: 100% inspection of all products across all 12 lines.
The future of vertebral restoration lies in the intersection of Bio-active Materials and Robotic Assistance. Our current roadmap includes:
Our kits adhere to the latest EU MDR standards, emphasizing clinical evidence and stringent biocompatibility testing. Unlike generic suppliers, we provide a complete system including specialized trocars, high-pressure injectors, and optimized PMMA cement.
Yes. We have a dedicated regulatory department that prepares localized dossiers for MOH registrations. Our MDSAP certification further streamlines approval in multiple global jurisdictions.
With 12 production lines and 120+ machines, we typically fulfill standard wholesale orders within 4-6 weeks, depending on customization requirements.
Absolutely. We provide comprehensive OEM/ODM services, including graphic processing, sample-based manufacturing, and customized instrument kit configurations to meet specific hospital procurement needs.
