TPU-based custom medical tubing engineered to your exact specifications — ISO 13485 & ISO 9001 certified, rigorously validated for biocompatibility and performance.
This high-performance medical tubing is manufactured exclusively to customer-provided engineering drawings — no off-the-shelf dimensions, no generic profiles. Built from medical-grade thermoplastic polyurethane (TPU), it delivers exceptional kink resistance, tensile elasticity, and smooth inner lumen integrity essential for catheter systems, fluid delivery lines, and minimally invasive device assemblies.
Designed for regulatory-ready integration, every production batch complies with ISO 13485:2016 (Medical Devices Quality Management) and ISO 9001:2015 (Quality Management Systems). We do not assign fixed sizes — instead, we translate your precise dimensional, wall-thickness, durometer, and functional requirements into validated, traceable tubing solutions.
No standard sizes. Every tube is produced strictly per your CAD drawings, GD&T callouts, and functional test criteria — ensuring perfect fit and performance in your final medical device assembly.
Manufactured in a dedicated Class 8 cleanroom environment under full ISO 13485:2016 compliance — with documented risk management, change control, and traceability down to raw material lot level.
Engineered for critical biocompatibility (USP Class VI, ISO 10993-5/-10 tested), consistent extrusion quality, and reliable flexibility across temperature ranges — ideal for medical tubing in dynamic applications.
Engineering team cross-checks your drawing against process capability, material behavior, and regulatory constraints before release to production.
Real-time monitoring of OD/ID tolerance, wall thickness uniformity, and surface finish during extrusion — with SPC charting and automated rejection.
Dimensional verification, burst pressure, kink resistance, and extractables testing per ISO 10993-12 — with full CoA and traceability documentation.
We specialize in low-volume, high-mix medical tubing customization — from single prototype runs to recurring production batches. Our support includes:
No. All our medical tubing is 100% custom-manufactured per client engineering drawings. We do not maintain standard size inventory or publish dimensional catalogs.
We are certified to ISO 13485:2016 and ISO 9001:2015. All processes, documentation, and validation activities comply with these standards — with full audit readiness and traceability.
Yes. While our base TPU materials are USP Class VI and ISO 10993-5/-10 tested, we coordinate full application-specific biocompatibility studies (e.g., ISO 10993-12 extraction, cytotoxicity, sensitization) through accredited third-party labs — included in project scope upon request.
Share your technical drawing, functional requirements, and target volume — we’ll deliver a compliant, validated quotation within 3 business days.
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