Custom OEM Medical Grade Silicone Tubing USP Class VI Biocompatible Platinum Cured Hose for Medical Device

1. Core Identity: A Critical Component for Life Science Applications

This is not an ordinary tube, but a high-purity precision component engineered for critical medical, pharmaceutical, and life science applications. We understand that in these fields, material performance is directly linked to patient safety and the accuracy of experimental results. Therefore, we manufacture every inch of our tubing to the most stringent standards.

2. Key Features & Advantages

• Ultimate Biocompatibility:
  Made from medical-grade, platinum-cured silicone, our tubing is non-toxic, odorless, and non-leaching. It causes no adverse reactions with human tissue, ensuring the highest level of safety for patient contact.

• Exceptional Purity:
  The platinum-curing process ensures an extremely low level of extractables, preventing any secondary contamination of transported drugs or sensitive fluids. This makes it the ideal choice for high-purity fluid transfer.

• Excellent Physical Performance:
  It features a wide temperature range (typically -50°C to 200°C), resistance to common chemicals, and high tear and kink resistance. It maintains long-term stability and integrity even in demanding applications like peristaltic pumps.

• Sterilizable:
  Our tubing can withstand multiple sterilization methods, including autoclave (steam), Ethylene Oxide (EtO), and Gamma Radiation, making it perfectly suited for sterile environments.

3. Core Application Areas

• Medical Devices: Used in fluid pathways for ventilators, dialysis machines, infusion pumps, and diagnostic equipment.

• Pharmaceutical & Biotech: Ideal for drug delivery systems, vaccine manufacturing, cell cultures, and fluid transfer in fermentation processes.

• Laboratories: Serves as tubing for peristaltic pumps, analytical instruments, and the transfer of high-purity reagents.

• Disposable Medical Supplies: Used in products such as catheters and drainage tubes.

4. Strict Compliance & Certifications

To clear the path for your products to enter international markets, our medical silicone tubing can be manufactured to meet or exceed one or more of the following globally recognized standards upon request:

• USP Class VI

• ISO 10993 (Biocompatibility)

• FDA 21 CFR 177.2600 (Food Contact)

• RoHS & REACH

5. Comprehensive OEM/ODM Customization Services

As a direct manufacturer, we offer full customization to meet your unique device designs and application needs:

• Precision Dimensional Control: We can produce tubing with extremely tight tolerances for inner diameter, outer diameter, and wall thickness.

• Hardness Customization: Shore hardness can be adjusted to meet specific flexibility or pressure-resistance requirements.

• Color & Marking: We can produce different colors for line identification or print markings on the tube surface.

• Special Packaging: Options include cleanroom packaging, individual sterile packaging, and more.