Views: 0 Author: Kevin Publish Time: 2025-07-14 Origin: Jinan Chensheng Medical Technology Co., Ltd.
In the medical device industry, precision, safety, and reliability are non-negotiable—especially for components like medical grade silicone tubes, which directly interact with patients, drugs, and critical bodily fluids. As a leading medical grade silicone tube factory based in China, Jinan Chensheng Medical Technology Co., Ltd. (www.jngxj.cn) specializes in manufacturing high-purity, biocompatible silicone tubes tailored to the stringent demands of global healthcare markets. With ISO 13485 certification, FDA compliance, and a state-of-the-art cleanroom production facility, we deliver medical silicone tubes that meet the most rigorous international standards. If you’re an overseas buyer seeking a trusted medical grade silicone tube factory partner for medical-grade tubing solutions, here’s why Chensheng Medical stands out as your ideal choice.
Medical grade silicone tubes are not ordinary industrial products—they are lifeline components used in applications such as:
Drug delivery systems (IV catheters, peristaltic pump tubes)
Surgical instruments (laparoscopic suction tubes, endoscope sheaths)
Patient monitoring (respiratory therapy circuits, dialysis tubing)
Wound care (drainage tubes, feeding tubes)
These applications demand a medical grade silicone tube factory with expertise in:
✅ Biocompatibility: No toxic leachables or allergic reactions
✅ Chemical inertness: Resistance to drugs, bodily fluids, and sterilization agents (autoclaving, ETO, gamma radiation)
✅ Mechanical stability: Consistent flexibility, burst strength, and dimensional accuracy under repeated use
✅ Regulatory compliance: Adherence to global standards (ISO 10993, FDA 21 CFR 177.2600, EU MDR)
Off-the-shelf tubing or non-specialized manufacturers often fail to meet these requirements. At Chensheng Medical, we’ve invested over a decade in perfecting the art and science of medical silicone tube production—making us a medical grade silicone tube factory trusted by medical device OEMs worldwide.
As a dedicated medical grade silicone tube factory, we combine advanced technology, strict quality control, and deep medical industry expertise to deliver tubes that exceed expectations. Here’s what sets our manufacturing capabilities apart:
The foundation of superior medical silicone tubes lies in raw material selection. We source only high-purity silicone rubber (platinum-cured, peroxide-free) from globally certified suppliers, ensuring:
Low extractables: <0.1% residue after ISO 10993-12 extraction testing
Biocompatibility: Compliant with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and USP Class VI standards
Chemical purity: Heavy metals <0.1ppm, volatile organic compounds (VOCs) <50ppm
Consistency: Batch-to-batch uniformity in hardness (Shore A 30–80), tensile strength (>7 MPa), and elongation at break (>300%)
Every material lot is accompanied by a Certificate of Analysis (CoA), and full traceability is maintained from raw material receipt to finished product shipment—a critical requirement for medical device regulatory submissions.
Medical grade silicone tubes demand sterile, controlled environments. Our medical grade silicone tube factory features:
Class 8 (ISO 14644-1) cleanrooms: For tube extrusion, cutting, and assembly, ensuring <352,000 particles/m³ (≥0.5μm)
Automated extrusion lines: 12 precision extrusion machines with closed-loop diameter control (±0.02mm tolerance) to avoid human contact
Sterile packaging: ISO 11607-compliant cleanroom packaging lines with ethylene oxide (ETO) sterilization options
This infrastructure eliminates contamination risks, making our tubes suitable for even the most sensitive applications, such as neonatal care and implantable devices.
No two medical devices are identical—and neither are their tubing needs. As a flexible medical grade silicone tube factory, we offer fully customizable solutions, including:
Customization Option | Capabilities | Medical Applications |
Dimensions | Inner diameter: 0.3mm–50mm; Outer diameter: 0.5mm–60mm; Length: 10mm–100m coils | Microcatheters, large-bore drainage tubes |
Wall Thickness | Uniform (0.1mm–10mm) or variable (tapered, stepped) | Balloon catheter shafts, pressure-sensitive tubing |
Reinforcements | Braided polyester/nylon, spiral steel, or embedded RFID chips | High-pressure drug delivery, kink-resistant lines |
Surface Treatments | Hydrophilic coating, anti-stick finish, or laser marking (for part numbering) | Catheters requiring lubricity, traceable components |
Colors & Opacifiers | Custom Pantone colors, radiopaque (barium sulfate/titanium dioxide) formulations | Diagnostic imaging tubes, color-coded fluid lines |
Our engineering team works closely with clients to develop custom tooling (dies, mandrels) and process parameters, with rapid prototyping (7–10 days) to validate designs before mass production.
At our medical grade silicone tube factory, quality is not an afterthought—it’s embedded in every process:
Raw Material Testing: Fourier-transform infrared (FTIR) spectroscopy to verify silicone purity; gas chromatography (GC) to detect volatile organic compounds (VOCs).
In-Process Inspection: Real-time laser diameter measurement, ultrasonic wall thickness testing, and visual inspection for defects (scratches, bubbles).
Finished Product Validation:
Mechanical testing: Burst pressure (>300 psi for standard tubes), tensile strength, compression set (<25% at 200°C/70h).
Sterilization validation: Compatibility with autoclaving (134°C/30min), ETO, and gamma radiation (25–50 kGy).
Regulatory documentation: Batch records, Certificate of Compliance (CoC), DMF support, and assistance with FDA 510(k) or CE marking submissions.
As a medical grade silicone tube factory serving clients in Europe, North America, and Asia, we maintain full compliance with regional regulations:
ISO 13485:2016: Certified quality management system for medical devices.
FDA 21 CFR 177.2600: Approved for food contact and medical applications.
EU MDR (2017/746): Compliance with European Medical Device Regulation.
China NMPA: Registered for domestic and export medical device components.
This regulatory expertise ensures seamless integration of our tubes into your medical devices, reducing time-to-market and compliance risks.
We understand that medical device development often involves tight deadlines. As a responsive medical grade silicone tube factory, we offer:
Emergency prototyping: 48-hour rush sampling for critical projects
Expedited production: 2-week lead time for small-batch orders (500–10,000 meters)
Dedicated project managers: 24/7 communication for time-sensitive inquiries
Our commitment to quality has made us a preferred medical grade silicone tube factory for leading healthcare companies:
European Respiratory Device OEM: Developed a custom 4mm ID/6mm OD silicone tube with braided polyester reinforcement for high-flow oxygen therapy. The tube withstood 10,000+ flex cycles without kinking, reducing patient discomfort and device returns by 32%.
US Diagnostic Equipment Manufacturer: Supplied radiopaque silicone tubing for contrast media delivery, meeting FDA 510(k) requirements and enabling 0.1mm precision in imaging applications.
Asian Pharmaceutical Client: Produced sterile, single-use peristaltic pump tubes with low protein binding (<0.5μg/cm²), ensuring accurate drug delivery in chemotherapy infusion systems.
When you choose Chensheng Medical as your medical grade silicone tube factory, you gain more than a supplier—you gain a partner invested in your success. We offer:
✅ Technical expertise: 15+ engineers specializing in medical silicone extrusion and material science.
✅ Cost efficiency: Competitive pricing without compromising quality, thanks to optimized production processes and economies of scale.
✅ Reliable delivery: 98% on-time delivery rate, with flexible MOQs (starting from 100 meters) to support small-batch trials and large-scale production.
✅ Multilingual support: English, German, and Spanish-speaking teams for seamless communication.
If you’re searching for a medical grade silicone tube factory that delivers precision, compliance, and customization, look no further than Jinan Chensheng Medical Technology Co., Ltd.
Take the next step:
Visit our website at www.jngxj.cn to view our medical tube product catalog and certification documents.
Send your specifications (dimensions, material requirements, application details) to info@jngxj.cn for a free quote and technical consultation.
Connect via WhatsApp at +86-18560016197 to speak directly with our medical tubing specialists.
Your patients deserve the best—trust a medical grade silicone tube factory that never compromises on safety or quality.
We look forward to partnering with you to advance global healthcare.
