CE/MDR & FDA Certified Silicone Medical Products Manufacturer info@silicone-medical.com | +86 17712779393
Overall Solution Provider for Silicone Medical Products

Innovative Silicone Medical Solutions for Global Healthcare

Steve Medical specializes in medical-grade silicone catheters, drainage systems, breathing circuits, and gastrointestinal nutrition tubes. All products are CE/MDR certified and FDA approved, manufactured under ISO 13485 quality management in a 100,000-class cleanroom environment.

14+

Years of Experience

20+

Technical Patents

60+

Countries Served

Silicone Negative Pressure Drainage System
CE
CE/MDR Certified
FDA Approved

Complete Silicone Medical Product Portfolio

From urology to gastroenterology, we deliver CE/MDR certified, FDA approved medical consumables trusted by healthcare providers in 60+ countries — featuring silicone devices, urinary collection systems, wound drainage, anesthesia & respiratory care, enteral nutrition, and excretion care products.

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Urology

Foley & Hematuria

Drainage

Wound & Thoracic

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Anesthesia & Respiratory

Breathing & Airway

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Gastroenterology

Feeding & Nutrition

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Excretion Care

Enema & Fecal

Silicone Foley Catheter

Silicone Foley Catheter

1-Way / 2-Way / 3-Way 6Fr-26Fr Latex-Free

100% medical-grade silicone, radiopaque line for X-ray visualization. Designed for short and long-term urinary drainage with superior biocompatibility.

Silicone Hematuria Catheter

Silicone Hematuria Catheter

6Fr-26Fr 50ml / 80ml Couvelaire Tip

Larger drainage holes prevent clogging from blood clots or debris. Ideal for urological surgery and postoperative hematuria management.

Foley Catheter 3-Way

3-Way Silicone Foley Catheter

14Fr-26Fr 30ml Balloon Continuous Irrigation

Three-lumen design enables simultaneous drainage and bladder irrigation. Used in urology for long-term treatment and post-TURP procedures.

Temperature Sensing Foley

Temperature Sensing Foley Catheter

16Fr-24Fr Built-in Sensor Real-time Monitoring

Integrated temperature sensor enables continuous core body temperature monitoring during urinary drainage, reducing the need for separate probes.

Urine Collection Bag

Urine Collection Bag

1000ml-5000ml Anti-Reflux Valve Latex-Free

Medical-grade PVC urine bag with anti-reflux valve preventing backflow. Breathable film reduces pressure, with rotation/flip/slide drain valve options for easy emptying.

Urine Meter

Urine Meter

Graduated Scale Precise Measurement EO Sterilized

Parent-child urine meter for accurate hourly urine output measurement in critical care. Clear graduations and sampling port for clinical monitoring.

Waste Fluid Collection Bag

Waste Fluid Collection Bag

2L / 3L Low Drain Valve Hanging Straps

Large-capacity waste fluid collection bag with secure closure system. Low-position drain valve and hanging straps for bedside use.

Anti-Reflux Drainage Bag

Anti-Reflux Drainage Bag

5000ml Deluxe / Economic Leg Bag Available

Premium anti-reflux drainage bag with integrated non-return valve. Available in deluxe, economic, and leg bag configurations for different mobility needs.

Foley Catheterization Tray

Foley Catheterization Tray

Complete Kit Sterile All-in-One

Complete sterile catheterization kit containing catheter, gloves, lubricant, antiseptic, and collection bag — everything needed for safe aseptic catheterization.

Our Competitive Advantages

Manufacturing excellence backed by rigorous quality control, deep customization capabilities, and global compliance expertise.

Qualified Quality

CE/MDR, FDA, and ISO 13485 certified. Products manufactured in a 100,000-class cleanroom with 100% online inspection to ensure the highest standards.

Custom R&D

Over 20 technical patents with a dedicated R&D team of 30+ engineers. Product design, mold development, and full customization capabilities from concept to production.

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Global Reach

Products exported to 60+ countries across Southeast Asia, South America, Europe, the Middle East, and beyond. Registered with multiple national health authorities.

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End-to-End Service

Comprehensive support from product customization, packaging design, to international logistics. We help you launch your medical device business faster with fewer hurdles.

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Global Healthcare
Serving 60+ Countries Worldwide
About Steve Medical

Your Trusted Partner in Silicone Medical Devices

Steve Medical Science & Technology Co. Ltd. is a specialized manufacturer of medical-grade silicone devices, established in collaboration with Shandong Steve Medical Technology Co. Ltd. — a leading factory with over a decade of proven manufacturing expertise.

We offer a comprehensive portfolio spanning urology, wound drainage, thoracic surgery, anesthesia, respiratory care, and gastroenterology. Every product is manufactured to CE/MDR and FDA standards in a certified 100,000-class cleanroom, with 100% online inspection ensuring zero-defect delivery.

100,000-Class Cleanroom Production
30+ R&D Engineers & 20+ Patents
ISO 13485 Quality Management System
100% Online Product Inspection
Custom Mold & Product Development
Full Packaging & Logistics Support

International Certifications

Every product meets the rigorous standards of leading global health authorities, ensuring compliance and patient safety worldwide.

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CE / MDR

European Medical Device Regulation compliance for unrestricted EU market access

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FDA

US Food & Drug Administration market approval for the American healthcare market

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ISO 13485

International quality management standard for medical device manufacturing

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CE Extension

Extended CE certification covering additional product categories and clinical applications

Europe (CE/MDR) USA (FDA) Southeast Asia Middle East South America

News & Insights

Stay informed about Steve Medical's latest innovations, industry events, and silicone medical technology advancements.

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January 28, 2026

Steve Medical to Exhibit at WHX Dubai 2026

Visit us at the 2026 Dubai World Healthcare Exhibition. We'll showcase our latest silicone catheter innovations and drainage solutions.

Read More →
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January 26, 2026

Silicone Foley Catheters Lead Urological Consumables Upgrade

Medical-grade silicone foley catheters are driving the global shift from latex to biocompatible alternatives in urological care.

Read More →
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January 23, 2026

Medical-Grade Silicone: Performance Benchmarks for Foley Catheters

An in-depth look at how material science advances in medical silicone are improving catheter performance, patient comfort, and infection resistance.

Read More →

Serving Healthcare Providers Worldwide

Our products are registered and distributed across key global markets

🇪🇺 Europe 🇺🇸 North America 🇯🇵 Brazil 🇲🇽 Mexico 🇩🇪 Middle East 🇪🇹 Malaysia 🇯🇳 Thailand 🇮🇳 Vietnam 🇳🇱 Indonesia 🇧🇷 Argentina 🇨🇴 Colombia

Contact Us

Ready to partner with us? Reach out for product inquiries, custom development, or partnership opportunities.

Let's Work Together

Whether you need standard products, custom development, or OEM services — our team is ready to support your medical device business.

Email

info@silicone-medical.com

Phone / WhatsApp

+86 17712779393

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Headquarters

No.1 Zhenxing Road, Dewu New District
Wucheng County, Shandong Province
China

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Working Hours

Monday – Friday, 9:00 AM – 6:00 PM (GMT+8)

Send Us a Message