Expertise & Innovation

Advanced Interventional & Urological Stent Manufacturing

Orthi Medical Co., Ltd. is a recognized ISO 13485-certified manufacturer specializing in high-performance vascular and urological stents. Engineered for clinical reliability, low recoil rates, excellent trackability, and optimal biocompatibility, our stent product line supports cardiovascular specialists and urologists worldwide.

Our manufacturing complex operates controlled ISO Class 7 cleanrooms equipped with high-precision laser cutting, electrochemical polishing, automated radial force inspection, and Co-60 / Ethylene Oxide (ETO) sterile packaging.

Why Procurement Teams Partner With Us

  • Medical-Grade Materials: Cobalt-Chromium (CoCr), 316L Stainless Steel, and Medical Polymer Polyurethane with radiopaque markers.
  • ISO 13485 & CE Compliance: Complete Technical Files, biocompatibility reports (ISO 10993), and registration support for fast market entry.
  • Full OEM/ODM Capability: Custom strut geometries, customized length/diameter specs, private labeling, and OEM tray packaging.
  • Sterile Assurance: Individually packaged sterile units meeting SAL 10-6 sterility assurance standards.
Product Catalog

High-Precision Stent & Catheter Solutions

Explore our specialized range of bare metal coronary stents, high-pressure balloon dilatation catheters, and urological double J stent kits.

Bare Metal Coronary Stent with Angioplasty Balloon Delivery System
Cardiovascular

Bare Metal Coronary Stent System

Balloon-expandable coronary stent pre-mounted on a high-flexibility delivery system. Features ultra-thin struts for fast endothelialization and reduced restenosis risk during percutaneous coronary intervention (PCI).

  • Material: Cobalt-Chromium / 316L SS
  • Nominal Pressure: 8 - 10 atm
  • Strut Thickness: ≤ 80 μm
High Pressure NC Balloon Dilatation Catheter
Cardiovascular

High Pressure NC Balloon Dilatation Catheter

Non-compliant (NC) high-pressure balloon catheter engineered for post-dilatation of coronary stents and recalcitrant calcified lesions with uniform expansion and minimal longitudinal growth.

  • Type: Non-Compliant (NC)
  • Rated Burst Pressure: 20 - 22 atm
  • Balloon Diameters: 2.0 - 4.5 mm
Double J Ureteral Stent Pigtail Catheter
Urology

Double J Ureteral Stent Catheter

Biocompatible polyurethane urological stent with dual pigtail ends. Designed for efficient renal drainage following ureteroscopy, lithotripsy, or urinary tract obstruction treatment.

  • Material: Thermoplastic Polyurethane
  • Sizes: 4.7 Fr - 8.0 Fr
  • Lengths: 24 cm - 30 cm
Complete Urology Double J Stent Kit
Urology Set

Double J Stent Urology Placement Kit

Integrated sterile procedure kit containing a Double J stent, PTFE-coated guidewire, and ergonomic pusher sleeve, facilitating smooth fluoroscopic and endoscopic insertion.

  • Kit Components: Stent + Guidewire + Pusher
  • Radiopaque: Full Length Barium Sulfate
  • Sterilization: Ethylene Oxide (ETO)
Coronary Stent Angioplasty Balloon Injector System
Interventional

Coronary Angioplasty Stent Delivery System

Advanced catheter delivery shaft with hydrophobic distal coating and soft tapered tip to ensure superior pushability and crossability in complex vessel anatomies.

  • Catheter Type: Rapid Exchange (Rx)
  • Guidewire Compatibility: 0.014 inch
  • Shaft Coating: Hydrophilic / Hydrophobic

Need technical specifications, OEM drawings, or bulk pricing for distributors?

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Technical Parameters

Product Specifications & Material Standards

Orthi Medical Co., Ltd. strictly complies with international ISO & ASTM medical material standards to guarantee high radial strength, optimal flexibility, and biocompatibility.

Stent Category Material Standard Radial Force / Burst Pressure Surface Treatment Sterilization Assurance
Bare Metal Coronary Stent Cobalt-Chromium (L605) / ASTM F138 316L High Radial Strength (≥ 1.2 bar) Electrochemical Mirror Polishing ETO Sterile (SAL 10-6)
NC Dilatation Balloon Medical Nylon / Pebax Polymer Rated Burst Pressure up to 22 atm Distal Hydrophilic Coating ETO Sterile (SAL 10-6)
Double J Ureteral Stent Medical Polyurethane (BaSO4 filled) Kink-Resistant Flexible Elasticity Biocompatible Low-Friction Finish ETO / Gamma Sterilization
Coronary Balloon Delivery Shaft PA / PEEK / Braided Stainless Steel Pushable Dual Lumen Construction Hydrophilic Outer Coating ETO Sterile (SAL 10-6)

ISO 13485 Certified

Full Quality Management System audit compliance for endovascular & surgical medical devices.

ISO Class 7 Cleanroom

Precision manufacturing, automated laser cutting, and packaging in certified cleanrooms.

100% Inspection

Every stent lot undergoes 100% optical dimensional checking, recoil measurement, and radial pressure testing.

Global OEM / ODM

Custom design, private label branding, and technical dossier support for international regulatory approval.

Distributor FAQ

Frequently Asked Questions Regarding Stent Sourcing

Key questions answered for procurement managers, medical distributors, and OEM partners evaluating Orthi Medical Co., Ltd.

What quality standards do Orthi Medical stent products meet?
Our manufacturing and quality systems operate under ISO 13485 and ISO 9001 certifications. Products carry CE compliance documentation. Raw materials comply with medical-grade ASTM and ISO standards, supported by material batch trace certificates.
Do you offer OEM, ODM, and private labeling for stent products?
Yes. Orthi Medical Co., Ltd. provides comprehensive OEM/ODM services including laser cutting according to client stent designs, custom strut dimensions, custom catheter lengths, private label sterile packaging, and regulatory documentation assistance.
Are stents supplied in sterile condition?
Yes. All coronary and urological stent products can be supplied individually packed in sterile blister pouches sterilized by ETO (Ethylene Oxide) or Gamma irradiation, maintaining a Sterility Assurance Level (SAL) of 10-6.
What is the typical lead time for OEM stent production orders?
Standard product orders are typically dispatched within 2 to 4 weeks depending on batch volume. Custom OEM/ODM orders requiring laser tool adjustment or prototype testing are completed according to agreed milestone schedules.

Partner with Orthi Medical Co., Ltd.

Request product technical dossiers or discuss OEM stent manufacturing with our engineering team at .

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