Explore our CE & MDR certified medical solutions, crafted utilizing high-precision injection molding and advanced material science to ensure optimal clinical outcomes.
Hangzhou RosMed Medical Co., Ltd. is a professional China medical consumables supplier specializing in disposable medical plastics, surgical non-woven products, and respiratory solutions. Since its establishment, RosMed has been committed to delivering safe, reliable, and high-quality healthcare products to global markets.
Over the years, the company has evolved from a focused manufacturer of basic disposable medical supplies into a comprehensive provider of integrated healthcare solutions. Through continuous investment in research and development, RosMed has expanded its product portfolio to cover urology consumables, anesthesia accessories, respiratory support components, and a wide range of non-woven and plastic medical products. Each stage of its development reflects a strong commitment to innovation, quality improvement, and adaptation to international healthcare standards.
With advanced production facilities and strict quality control systems, Hangzhou RosMed Medical Co., Ltd. ensures that all products meet global certifications and regulatory requirements. The company also actively supports OEM and ODM services, enabling partners to develop customized solutions tailored to specific market needs. Driven by a customer-centric philosophy, RosMed has built long-term partnerships with distributors, hospitals, and healthcare organizations worldwide.
Navigating complex international medical standards (EU MDR 2017/745, FDA, ISO) with localized validation, multilingual labeling, and comprehensive technical files.
Our entire surgical and respiratory lineup—including complex closed suction systems and anesthesia circuits—is manufactured to meet the rigorous demands of the European Medical Device Regulation (MDR 2017/745). We maintain updated clinical evaluation reports (CER) and post-market clinical follow-up (PMCF) registries, allowing European distributors seamless market access.
We actively collaborate with authorized representatives in the EU (EC Rep) and other target regions. We offer complete technical dossiers in CTD format, assist in regional product registrations (e.g., MHRA, ANSM, BfArM), and support custom multilingual packaging with localized instructions for use (IFU).
Sterility assurance is vital for surgical equipment. We validate all sterile products according to ISO 11135 (Ethylene Oxide sterilization) or ISO 11137 (Gamma irradiation). Regular bioburden monitoring, endotoxin testing, and sterile barrier integrity testing (ASTM F1929) are standard protocols.
Hangzhou RosMed Medical Co., Ltd. capitalizes on China's highly advanced medical industrial clusters. Our strategic location enables us to secure premium raw materials (such as biocompatible Pebax, medical-grade PVC, and PTFE) at optimal pricing. This enables us to pass significant cost savings to our global clients without compromising safety.
Our core strength lies in vertical integration. By handling precision injection molding, catheter extrusion, cleanroom assembly, packaging, and in-house sterilization under one roof, we eliminate intermediate delays and retain 100% control over product parameters.
From dual-durometer Pebax tubing to high-performance PTFE linings, we specialize in high-spec raw material processing to support advanced surgical procedures.
| Material/Process | Clinical Properties & Characteristics | Typical Applications | Compliance Standards |
|---|---|---|---|
| Pebax® Extrusion | Variable stiffness, superior torque transmission, excellent biocompatibility, kink resistance. | Multi-lumen catheter shafts, vascular access, precision medical tubing. | ISO 10993, USP Class VI |
| PTFE Liners | Ultra-low coefficient of friction, high temperature resistance, chemical inertness. | Pumping system tubes, delivery sheath inner liners, chemical dosing. | FDA 21 CFR 177.1550 |
| SMS Non-woven | Tri-layer protection, high hydrostatic pressure resistance, fluid repellent, breathable. | Surgical drapes, sterile eye packs, patient gowns, isolation wraps. | AAMI Level 3 / Level 4, EN 13795 |
| Liquid Silicone (LSR) | Hyperallergenic, high elasticity, thermal stability, excellent seal integrity. | Jackson-Pratt drainage reservoirs, ventilator bellows, medical seals. | USP Class VI, ISO 10993-5 |
Our product lines are designed to integrate seamlessly into high-stakes clinical settings, providing safety for patients and ease of use for healthcare professionals.
In critical care environments, prolonged mechanical ventilation is a common life-support mechanism. Our Closed Suction Systems allow clinicians to perform endotracheal suctioning without disconnecting the patient from the ventilator circuit. This preserves airway pressure, maintains positive end-expiratory pressure (PEEP), and prevents cross-contamination, lowering the incidence of Ventilator-Associated Pneumonia (VAP).
Patient safety during general anesthesia depends on a reliable gas delivery path. Our pediatric and adult Anesthesia Breathing Circuits incorporate high-efficiency Heat and Moisture Exchangers (HME) and filters. They retain the patient’s natural respiration warmth and humidity while filtering pathogens, ensuring stable ventilation throughout surgical operations.
Managing fluid accumulation after major procedures prevents hematomas and surgical site infections. Our Jackson-Pratt Silicone Closed Suction Systems leverage light negative pressure drainage. They ensure consistent evacuation of exudate without tissue trauma, supporting rapid tissue recovery and patient mobilization.
The global surgical consumables market is shifting towards specialized raw materials, tighter regulatory compliance, and a strong push for sustainability. With the EU MDR enforcement, low-quality manufacturers are being phased out. Modern hospitals demand partners who can prove clinical efficacy, structural biostability, and low environmental impact.
"The integration of smart sensory components within closed systems and the transition to non-phthalate plasticizers (DEHP-free) are no longer premium choices; they have become standard requirements for tender processes across Western Europe and North America."
As a forward-thinking supplier, Hangzhou RosMed Medical Co., Ltd. continues to invest in raw material research and green packaging initiatives. We aim to reduce environmental footprint during manufacturing and supply eco-friendly surgical solutions that support the circular economy goals of global healthcare networks.
Inside RosMed's advanced manufacturing center: where precision injection molding, cleanroom assembly, and strict chemical quality control happen.
Explore our anesthesia circuits, customized drapes, medical tubings, and specialized protective wears engineered for the sterile field.
How we address long lead times, customs barriers, and sterilization requirements for hospital groups and distributors.
Managing multiple vendors for extrusion tubing, custom non-woven gowns, and injection-molded fittings increases administrative overhead. RosMed serves as a single source of manufacturing, consolidating diverse medical lines into single-shipment containers to optimize logistics and lower customs duty overhead.
Customs entry for sterile medical goods requires flawless microbiological documentation. We provide sterilization run sheets, biological indicator test results, and residual EtO level certificates with every shipment, preventing clearance delays at critical ports.
To counter ocean transit volatility, we support safety stock contracts. Under annual blanket purchase agreements, we manufacture and store reserve quantities in our warehouses. This ensures rapid dispatch when market demand spikes.
Answers to critical questions asked by compliance managers, procurement officers, and clinical engineers.
RosMed Medical
