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.

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14+

Years of Experience

20+

Technical Patents

60+

Countries Served

Silicone Foley Catheter by Steve Medical
CE
CE/MDR Certified
FDA Approved
Our Products

Complete Silicone Medical Product Portfolio

From urology to gastroenterology, we deliver CE/MDR certified, FDA approved silicone devices trusted by healthcare providers in 60+ countries worldwide.

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Urology

Foley & Hematuria

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Drainage

Wound & Thoracic

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Anesthesia & Respiratory

Breathing & Airway

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Gastroenterology

Feeding & Nutrition

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.

Why Choose Us

Our Competitive Advantages

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

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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.

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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
Quality Assurance

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
Latest Updates

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
Get in Touch

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.

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Email

info@silicone-medical.com

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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)

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