+86 16601773197
info@yukmed.com
Shanghai, China
OEM & ODM Medical Partner

Medical devices, made to your specification.

From catheters to guidewires and production equipment — we deliver end-to-end manufacturing, development and testing under one roof in Shanghai.

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ISO 13485 Certified facility
40+ Countries Global distribution
Full QC Testing Before every shipment
Medical device production facility with precision equipment and technicians
Precision Manufacturing

Medical Device Manufacturing

OEM & ODM — Customizable dimensions

10+
Years of experience
40+
Countries served
200+
Active clients
100+
Product models
Two cleanroom technicians working together on a medical device
Precision starts with our people
About Us

Your partner in medical device innovation.

From an idea to a finished device, we bring engineering expertise and careful craftsmanship to every step.

Based in Shanghai, YUKMED develops catheters, guidewires and specialized production equipment for medical device brands worldwide. Our integrated OEM and ODM approach connects product development, prototyping and manufacturing under one roof.

  • Custom OEM & ODM development
  • In-house engineering & tooling
  • Dedicated cleanroom manufacturing
  • Support from prototype to production
Let’s build something better
OEM & ODM Medical Device Portfolio

Precision engineered.
Built for your next breakthrough.

Manufactured in our ISO 13485 cleanroom facility. Available as standard configurations or fully customized OEM/ODM catheter and guidewire solutions.

ISO 13485 manufacturing Customized to your specifications
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Can't find the exact catheter specification?

We produce customized prototypes within 2–4 weeks based on your engineering requirements.

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Medical Engineering & Contract Manufacturing

Comprehensive Interventional Technology Services

From initial CAD prototyping and micro-tolerance polymer extrusion to high-volume cleanroom assembly and automated line equipment, YUKMED delivers turnkey contract solutions for global healthcare brands.

Cleanroom Automated Line
Cleanroom technicians working on a precision medical manufacturing line
Dynamic Burst & Hydrostatic QC
01 / AUTOMATION PLC Multi-Axis Precision Motion
02 / HYDRAULICS High-Pressure Burst & Static Flow
03 / TRACEABILITY Real-Time Sensor Calibration Logs
Core Contract Capabilities

End-to-End Solutions for Interventional Technologies

Precision engineering and specialized cleanroom manufacturing designed to accelerate clinical validation and full commercialization.

ISO 13485 Production

OEM Contract Manufacturing

High-volume cleanroom manufacturing of finished catheters, guidewires, and braided access sheaths under strict ISO 13485 quality systems.

  • Class 10,000 (ISO 7) cleanroom sterile assembly
  • Multi-lumen extrusion, braiding & laser cutting
  • 100% burst QC & full DHF batch traceability
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2–4 Wks Prototyping

ODM Co-Development & R&D

Turn innovative clinical ideas into functional bench and animal test samples in 2–4 weeks with custom multi-lumen profiles and FEA simulations.

  • Rapid functional bench & animal test prototypes
  • Custom hydrophilic coating & balloon forming
  • Finite element analysis (FEA) & trackability testing
Start Prototyping
Discuss Your OEM Project Download Capabilities Matrix
Global Clinical Trust & Partnerships

Built on precision.
Strengthened by partnership.

See why cardiovascular, neurovascular, and OEM brands across North America, Europe, and Asia-Pacific trust YUKMED for precision catheter development and high-volume contract manufacturing.

3-Week DHF Prototypes

“YUKMED compressed our microcatheter development timeline significantly. Delivering clinical-grade functional samples in under 3 weeks accompanied by rigorous burst data and DHF documentation allowed us to achieve CE mark filing 4 months ahead of schedule.”

MV

Dr. Marcus Vance

VP of Research & Development • Boston, USA

100% Audit Compliance

“The 1:1 torque responsiveness and dimensional wall stability of YUKMED's multi-durometer braided access sheaths are remarkable. Their Shanghai cleanroom audit was flawless, and the complete ISO 13485 quality packet made our FDA 510(k) submission seamless.”

ER

Elena Rostova

Senior Director of Regulatory Affairs • Munich, Germany

Line Equipment Synergy

“We sourced both our steerable catheter contract production and the vertical laminator line equipment directly from YUKMED. Having one engineering partner that manufactures both the catheter and the machine eliminated tooling mismatches entirely.”

JL

Jean-Pierre Laurent

Chief Technology Officer • Geneva, Switzerland

99.4%
In-Line QC Pass Rate
50+
Global Export Markets
2–4 Wks
Prototyping Turnaround
Class 10k
ISO 7 Cleanroom Base
Technical Guidance & Compliance FAQs

Frequently Asked Questions

Get clear, detailed answers regarding our OEM/ODM interventional engineering capabilities, cleanroom standards, dimensional tolerances, and regulatory filing support.

Initial functional prototypes—including custom multi-lumen extrusions, composite braided shafts, and specialized distal tip geometries—are typically engineered and shipped within 2 to 4 weeks. Every prototype batch is accompanied by destructive burst verification data and preliminary Design History File (DHF) documentation.
Our Shanghai manufacturing base operates under strict ISO 13485:2016 quality management systems. All catheter assembly, automated braiding, hydrophilic coating, and sterile packaging take place in certified ISO Class 7 (Class 10,000) and Class 8 cleanrooms with real-time particle count and environmental micro-monitoring.
We achieve wall thickness tolerances down to ±0.005mm (5 microns) on ultra-thin PTFE liners and multi-durometer Pebax/Nylon shafts. Our variable-pitch 16-wire and 32-wire braiding systems allow smooth, continuous stiffness transitions along the catheter shaft for optimal pushability and 1:1 torque responsiveness.
Yes. We maintain dedicated R&D pilot cells configured for agile, low-volume design verification batches (50–500 units), alongside fully automated, validated production lines capable of scaling seamlessly to hundreds of thousands of units per month under IQ/OQ/PQ protocols.
Yes. YUKMED delivers turnkey technical dossiers including biocompatibility certifications (ISO 10993), tensile and burst strength verification (ISO 10555), packaging sterile barrier validation, and complete DHF files formatted directly for CE MDR Technical Documentation and US FDA 510(k) clearances.
Yes. YUKMED designs and manufactures proprietary cleanroom equipment, including tip thermoforming machines, vertical hot-air laminators, continuous hydrophilic coating lines, and hydrostatic burst testers, customized with multi-axis PLC automation for medical cleanrooms worldwide.
Whitepapers & Technical Insights

Latest In Medical Device Technology

Stay informed with technical breakdowns, cleanroom manufacturing breakthroughs, and regulatory guides authored by YUKMED’s biomedical engineers.

YOUR NEXT BREAKTHROUGH STARTS HERE

Ready to Accelerate Your Interventional Device Project?

From rapid CAD prototyping to high-volume ISO 13485 cleanroom assembly and turnkey line equipment, partner with YUKMED for clinical-grade precision.

Request OEM / ODM Quote +86 16601773197