OEM/ODM Surgical Instruments Supplies Supplier & Exporters

Premium Clinical Consumables & Custom Contract Manufacturing Services for Global Healthcare Systems. Certified Cleanroom Molding, Extrusion, and Sterile Packaging Solutions conforming to CE MDR & ISO 13485.

ISO 13485:2016 Certified
CE MDR Compliant
Class 100,000 Cleanroom
OEM/ODM Tooling Support

Pioneering Cleanroom Engineering & Sterile Consumable Supply

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. Today, it continues to grow as a trusted supplier in the medical consumables industry, dedicated to improving patient safety and supporting modern healthcare systems globally.

100k
Clean Room Class
15+
Years Experience
80+
Countries Exported
RosMed Office Entrance
RosMed Cleanroom Facility

Advanced Facilities & Production Line Gallery

A visual walkthrough of our ISO 13485 certified cleanroom manufacturing floors, R&D labs, and quality validation sectors.

Analyzing Global Procurement Dynamics

How we address the core challenges of healthcare procurement managers, clinical distributors, and OEM medical device brands.

Regulatory & Clinical Conformity

Global medical networks face tightening compliance constraints. Our facilities ensure that polymer selection, manufacturing pathways, and sterilization protocols meet strict ISO 10993 biocompatibility requirements and CE MDR certification guidelines, providing seamless regulatory passage.

Total Supply Chain Security

Single-sourcing is a vulnerability. We mitigate raw material shortages through direct contracts with global medical-grade resin and polymer producers. Leveraging our strategic location near major ocean cargo hubs, we ensure continuous inventory supply and resilient shipping pipelines.

Custom Mold & Tooling R&D

Off-the-shelf devices do not always fit specialized surgical interfaces. Our experienced engineering division leverages advanced CAD/CAM software to design custom molds, facilitating rapid prototyping of silicone, PVC, and TPU components with strict dimensional tolerances.

China Factory 4.0: Smart Manufacturing Excellence

Unifying mechanical automation, real-time quality loops, and Lean logistics to optimize production yields and lower lead times.

Automated Cleanroom Injection

Our primary molding lines are located within Class 100,000 cleanrooms. Automated material feeding and robotic demolding ensure zero skin contact, minimizing bioburden levels and particulate contamination before final sterilization.

Micro-Extrusion & Catheter Engineering

Producing single and multi-lumen suction systems requires high structural integrity. Our advanced extrusion processes control outer diameter variances down to ±0.05 mm, preventing catheter kinking during negative-pressure suctioning.

Rigorous Quality Inspection Loops

Every batch of medical consumables is verified via CCD visual inspection systems, automated pressure decay testing for seal integrity, and tensile tests. Post-sterilization chemical residues are verified to ensure patient safety.

Macro Industry Solutions & Clinical Applications

Integrated product configurations tailored to anesthesia, critical care ventilation, and high-risk surgical operations.

Anesthesia Support Systems

We supply reusable and disposable silicone breathing circuits, masks, and laryngeal mask airways (LMAs). Our medical-grade silicone components guarantee optimal sealing pressures to minimize gas leaks while reducing mucosal irritation during intubation.

Infection Control & Barrier Defense

Our non-woven medical division produces disposable isolation gowns, surgical drapes, and protective face masks. Engineered with SMS and laminated materials, these products offer high hydrostatic pressure resistance to block bodily fluids and pathogens in sterile fields.

Intensive Care Unit Closed Suction

VAP (Ventilator-Associated Pneumonia) is a major concern in mechanical ventilation. Our closed suction systems allow airway clearance without disconnecting the patient from the ventilator, preserving airway pressure and minimizing contamination risks.

Technology Roadmap & Future Outlook

Our product strategy integrates smart design, sustainable polymers, and digital quality monitoring to support modern clinical trends.

Phase 1

Eco-Friendly Medical Grade Polymers

Developing bio-sourced non-phthalate plasticizers and compostable non-woven substrates for medical barrier textiles, reducing the carbon footprint of medical waste disposal without compromising sterile protection.

Phase 2

Smart Catheter Systems

Integrating colorimetric indicators and low-friction hydrophilic coatings onto closed suction catheter systems to reduce mucosal trauma during rapid emergency procedures.

Phase 3

Custom Micro-Molding & Multi-Lumen Co-Extrusions

Expanding manufacturing lines for ultra-fine micro-fluidic channels and co-extruded tubing using specialized thermoplastics, catering to advanced endoscopic and minimally invasive surgical applications.

Localization Support & Global Compliance Assurance

Navigating customs, sterile certifications, and local regulations to ensure consistent, secure product delivery.

CE MDR Technical Documentation

Our dedicated regulatory department maintains complete Technical Files for all Class I, Is, and IIa/IIb medical devices, helping overseas partners fast-track local registration and compliance approvals.

ETO / Gamma Sterilization Validation

All sterile shipments are backed by detailed validation certificates (EN ISO 11135 / EN ISO 11137). We monitor biological and chemical indicators in every batch to guarantee sterility assurance levels (SAL) of 10^-6.

Global Logistics & Customs Clearance

We provide comprehensive FOB, CIF, and DDP delivery terms. By partnering with international freight forwarders, we ensure timely custom clearance and secure routing to key logistics centers.

ISO 13485 CERTIFIED
CE MDR REGISTERED
FDA IN PROGRESS
GMP COMPLIANT

Strategic Procurement & Technical FAQ

Detailed answers regarding customization, raw material sourcing, regulatory compliance, and OEM/ODM partnerships.

What are your OEM/ODM tooling costs and average lead times?
Tooling costs depend on product geometry, mold complexity, and cavity numbers. Typically, simple extrusion tools range from $1,500 to $3,500, while multi-cavity injection molds range from $5,000 to $20,000. DFM (Design for Manufacturing) feedback is delivered within 5 business days, with first-article samples produced within 30 to 45 days after design approval.
How does RosMed ensure compliance with the new EU MDR requirements?
We update our technical documentation to meet Regulation (EU) 2017/745 standards. This includes maintaining Post-Market Surveillance (PMS) data, performing biological safety evaluations under ISO 10993, and assigning UDI (Unique Device Identification) codes for clear traceability through the EUDAMED database.
What polymer grades are used for your anesthesia masks and respiratory circuits?
We use medical-grade, USP Class VI polymers. Reusable circuits and masks are made from high-strength addition-cure liquid silicone rubber (LSR), which withstands autoclaving. Disposable products are made from phthalate-free, clinical-grade PVC or thermoplastic elastomers (TPE).
What are the MOQ (Minimum Order Quantity) specifications for custom packaging?
Standard items packaged in our branded boxes require a low MOQ, often between 1,000 and 5,000 units. Custom OEM packaging, including customized Tyvek pouches or private label thermoformed blister packs, typically requires a minimum run of 10,000 to 20,000 units due to sterile packaging roll setup constraints.
Do you offer sterilization validation reports for third-party medical audits?
Yes. We provide complete sterilization batch records, ETO gas residue reports (in compliance with ISO 10993-7), and biological indicator incubation results with every sterile order, ensuring complete traceability for external audits.