Why Jinan Chensheng Stands Out as Your Go-To Medical Silicone Tubing Manufacturer

Hi there, I’m Kevin, Sales Manager at Jinan Chensheng Medical Technology—and if you’re in the market for medical silicone tubing, you know this isn’t a “one-size-fits-all” purchase. It’s a critical part of life-saving devices and patient care systems, so getting it right matters. Today, I want to pull back the curtain on why so many medical device OEMs, hospitals, and distributors worldwide trust us as their go-to medical silicone tubing manufacturer. Let’s dive in.

First off, let’s get one thing clear: medical silicone tubing isn’t a commodity. You can’t cut corners on precision, biocompatibility, or reliability—not if you want to keep patients safe and your devices performing at their best. That’s why we built our entire process around those three non-negotiables. Let me break down what that actually means for you.

We Start with Materials That Put Patient Safety First

Every tube we make uses platinum-cured silicone rubber—no peroxide catalysts here. Why does that matter? Peroxide can leave harmful residues, and that’s a risk we won’t take. With platinum curing, we guarantee:

• Biocompatibility you can verify: We meet ISO 10993-5 (no cytotoxicity), ISO 10993-10 (no irritation), and USP Class VI standards. This isn’t just paperwork—these are the benchmarks that let you use our tubing in direct contact with patients.

• Ultra-low extractables: Less than 0.1% leachables, per FDA 21 CFR 177.2600. For devices that stay in contact with bodily fluids long-term? That’s a must.

• Heavy metal control you can trust: We test every batch with ICP-MS, and our lead, mercury, and arsenic levels are always under 0.1ppm. No surprises, just peace of mind.

Our Manufacturing & Quality Control? Obsessive (In the Best Way)

We don’t just “make tubing”—we make it in Class 8 cleanrooms (that’s ISO 14644-1 compliant) with fully automated extrusion lines. Why the fuss? Because consistency and precision save you headaches down the line. Here’s what that translates to:

• Tight dimensional tolerance: ±0.02mm for inner diameters (0.3mm–50mm) and outer diameters (0.5mm–60mm). If your device needs a specific fit, we won’t miss the mark.

• Mechanical properties you can count on: Tensile strength over 7 MPa, elongation above 300%, and Shore A hardness between 30–80. Our tubing holds up to real-world use, whether it’s in an IV line or a surgical tool.

• Testing that leaves no room for error: Every batch goes through tensile testing (per ISO 37), sterilization validation (autoclave, ETO, gamma—whatever you need), and a full visual inspection. Our rejection rate? Less than 0.5%. That’s how we keep your production on track.

We’ve Got a Tube for Every Healthcare Need

As a full-service medical silicone tubing manufacturer, we don’t just offer “standard” products—we cover the gamut of what you might need for your devices. Here’s a quick look:

Our OEM Services: We’re Your Partner, Not Just a Supplier

I hear it all the time from clients: “We need something custom.” Medical device innovation doesn’t fit in a box—and neither do our OEM capabilities. Here’s how we work with you:

1. We Help You Design the Right Solution

Our R&D team has 15+ medical device engineers who don’t just “take orders”—they collaborate. Need a tube that stands up to autoclaving? We’ll pick the right material. Want a prototype fast? We turn them around in 7–10 days. And we’ll help with validation too: DFMEA analysis, performance test reports—whatever you need to get your design approved.

2. We Scale with You (No Matter Your Size)

• Low MOQs for custom projects: Start with as little as 500 meters if you’re testing a new design.

• Bulk capacity when you need it: We can produce 100,000+ meters a month—we even fulfilled a 500,000-meter quarterly order for an EU client last year.

• Tooling cost help: If your cumulative orders hit 10,000 meters, we’ll reimburse 50% of your tooling costs. That’s our way of investing in your success.

3. We Take the Headache Out of Compliance

Regulatory paperwork is no one’s favorite part—but it’s non-negotiable. We provide:

• Batch-specific Certificates of Analysis (CoA) with full traceability (so you can track every tube back to its source).

• Sterilization validation reports (ISO 11135 for ETO, ISO 17665 for autoclaving).

• A DMF assistance package to help with FDA 510(k) submissions. We don’t just hand you a tube—we help you get your device to market.

Why Jinan Chensheng? It’s Simple: We Deliver on Our Promises

I’ve been in this industry long enough to know trust is earned, not given. Here’s why our clients stick with us:

• Certifications you can verify: ISO 13485:2016 (our QMS is rock-solid), FDA 21 CFR 177.2600 compliance, and we’re ready to support EU MDR (2017/746) for CE marking. No empty claims—just paperwork you can audit.

• Partnerships that drive results: We worked with a European OEM on radiopaque catheter tubing for cardiovascular devices—and they saw a 40% drop in clinical placement errors. A US surgical brand uses our custom reinforced tubing for laparoscopic tools, and we’ve hit 99.7% on-time delivery for them over 3 years. Those wins are our wins.

• Support that doesn’t stop at sale: Our pricing is competitive (FOB Qingdao, with tiered discounts for bulk orders), and we offer 24-hour technical support in English, German, and Spanish. If you have a question at 2 AM? We’ll get back to you.

Ready to Talk About Your Project?

If you’re looking for a medical silicone tubing manufacturer that combines precision, compliance, and flexibility—you’re in the right place. Whether you need a standard tube or a fully custom solution, we’re here to help you make your medical devices safer and more effective.

• Check out our full product list: Medical Silicone Rubber Products

• Learn more about who we are: Our Company Story

• Reach out directly: Send your requirements to info@jngxj.cn, visit our contact page, or shoot me a WhatsApp at +86-531-12345678.

At Jinan Chensheng, we don’t just make medical silicone tubing—we make sure it works for you and the patients you serve. I’m looking forward to hearing from you.

— Kevin, Sales Manager

Jinan Chensheng Medical Technology Co., Ltd.