Top China Double J Stent Manufacturer & Suppliers Serving the Israel Market

CE MDR & ISO 13485 Certified Medical Polymer Solutions Engineered for Israeli Health Maintenance Organizations (HMOs), Municipal Hospitals, and Endourology Centers

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36+
Years Manufacturing Excellence (Est. 1988)
70+
Global Export Markets Served
ISO 13485
Clean Room Certified Facilities
100%
Batch Traceability & EO Validated
Clinical Polymer Technology

Next-Generation Double J Stent Architecture for Israeli Hospitals

In contemporary endourology, the Double J Stent (ureteral stent) plays a vital clinical role in maintaining ureteral patency, mitigating postoperative strictures, facilitating stone fragment passage following extracorporeal shockwave lithotripsy (ESWL) or ureteroscopy (URS), and restoring urinary drainage in obstructive nephropathy.

As a premier original equipment manufacturer (OEM) and supplier exporting directly to Israel, our manufacturing infrastructure combines medical-grade aromatic polyurethane (TPU) and biocompatible silicone formulations. Our stents feature advanced thermo-sensory compliance: maintaining optimal structural rigidity at room ambient temperature for effortless fluoroscopic positioning, and softening dynamically at 37°C intra-body temperature to reduce vesicoureteral reflux (VUR) and trigonal irritation.

  • Hydrophilic Polyvinylpyrrolidone (PVP) Coating: Reduces friction coefficient to <0.02, ensuring trauma-free insertion through tortuous ureteral anatomy.
  • Radiopaque Loading: Formulated with 20% to 30% Bismuth Subcarbonate / Barium Sulfate for continuous clear visualization under C-arm fluoroscopy and radiogram monitoring.
  • Optimized Drainage Hydraulics: Precision-punched multi-flume side holes preventing lumen collapse and optimizing luminal and extraluminal fluid dynamics.
  • Memory-Coil Retention Pigtails: Dual-end pigtails engineered with superior elasticity memory to prevent proximal upward migration or distal extrusion into the urinary bladder.
Material Science Matrix

Biocompatibility & Encrustation Resistance

Urolithiasis and ureteral obstructions represent significant clinical loads in Mediterranean healthcare environments. Extended indwelling times frequently lead to biofilm formation, bacterial colonization (e.g., Proteus mirabilis), and urinary salt encrustation.

Our engineering team utilizes proprietary fluoropolymer extrusion technologies and ultra-smooth surface finishing protocols. By eliminating microscopic extrusion micro-voids, our Double J Stents significantly diminish bacterial adhesion sites, extending safe indwelling intervals for short-term (up to 30 days) and long-term (up to 365 days) oncology indications.

"Technical Specification Note for Israeli Procurement Directors: All Double J Stent kits supplied to the Israeli market come pre-assembled or co-packaged with PTFE-coated nitinol guidewires, pushers, and radiopaque clamps, meeting Ministry of Health (MOH) AMAR regulatory guidelines."

Localized Clinical Application Scenarios Across Israel’s Health Systems

Israel’s public and private healthcare sectors—anchored by leading Health Maintenance Organizations (HMOs: Clalit, Maccabi, Leumit, and Meuhedet) alongside world-renowned medical centers such as Sheba Medical Center (Tel Hashomer), Hadassah University Medical Center, Rambam Health Care Campus, and Soroka Medical Center—demand uncompromised device performance, tight tolerance specifications, and continuous supply chain reliability.

1. Acute Urolithiasis & Emergency Lithotripsy (RIRS / PCNL / ESWL)

Due to regional climatic factors in Southern and Central Israel, metabolic kidney stone disease presents at high frequencies. Following Flexible Ureteroscopy (RIRS) or Percutaneous Nephrolithotomy (PCNL), edema at the ureteropelvic junction (UPJ) or ureterovesical junction (UVJ) can impede renal outflow. Our 4.7 Fr to 8.0 Fr Double J Stents provide immediate obstruction relief, facilitating the passage of residual stone dust while preventing renal colic and hydronephrosis.

2. Urological Oncology & Extrinsic Compression Management

For patients suffering from retroperitoneal fibrosis, pelvic malignancies, or gynecological tumor compressions causing ureteral strictures, long-term silicone and high-durometer polyurethane Double J Stents offer high circumferential radial strength. They resist extrinsic compression, maintaining patent urine flow from the renal pelvis to the bladder over 6 to 12-month indwelling periods without structural deformation.

3. Reconstructive Urology & Renal Transplantation

In surgical procedures such as pyeloplasty, ureteroureterostomy, and kidney transplants performed in surgical suites across Tel Aviv, Jerusalem, and Haifa, our pediatric and adult Double J Stents (3.0 Fr to 6.0 Fr; 10 cm to 30 cm lengths) serve as critical internal splints. They protect anastomotic lines, promote mucosal healing, and diminish the incidence of urine leaks or postoperative stricture formation.

4. Integrated Vascular & Dialysis Access Care

Recognizing that end-stage renal disease (ESRD) patients frequently present with concurrent urological complications, our manufacturing facilities also supply high-flow tunneled hemodialysis catheters, central venous access kits, and AV fistula accessories. This holistic nephro-urology portfolio enables medical distributors in Israel to streamline their tender sourcing from a single, vertically integrated manufacturer.

Product Engineering Comparison: Mediplus DJ Stents vs. Standard Market Alternatives

The table below highlights the physical, mechanical, and biological benchmarks of our ureteral stent series engineered for high-demand clinical environments.

Performance Parameter Our OEM Double J Stent Series Standard Market Alternatives Clinical Advantage for Israeli Hospitals
Biomaterial Formulation Thermosensitive Medical Polyurethane / Pure Silicone Generic Low-Grade PVC or Hard Polyurethane Softens at body temperature (37°C), dramatically reducing patient bladder spasms & pain.
Coating Coefficient of Friction Hydrophilic PVP (< 0.02 µ) Uncoated / Basic Silicone Oil (> 0.15 µ) Provides effortless placement over guidewires without ureteral mucosal abrasion.
Radiopacity Level 28% Bismuth Subcarbonate Content 12% - 15% Barium Sulfate Crystal-clear visibility under low-dose C-arm fluoroscopy, shortening operative exposure time.
Coil Retention Force High Elastic Memory Double Pigtail Moderate Shape Memory Prevents stent displacement or upward migration during active physical patient movement.
Sterilization Standard Ethylene Oxide (EO) ISO 11135 Validated Basic Gamma / Unvalidated EO Ensures 10⁻⁶ Sterility Assurance Level (SAL) with residual limits far below EU/Israeli MOH caps.

Israel Medical Device Market Trends & Regulatory Environment

The Israeli medical device sector operates under strict regulatory oversight administered by the MOH Medical Devices Division (AMAR). Medical importers and hospital procurement teams require fast-track registration access, comprehensive technical dossiers, and absolute compliance with European Union Medical Device Regulation (EU MDR 2017/745) and ISO 13485:2016 standards.

Key market dynamics driving urological purchasing in Israel include:

  • Shift Toward Day-Surgery & Minimally Invasive Endourology: Increased preference for hydrophilic, easy-to-remove stents that facilitate ambulatory discharge.
  • Preference for Complete Procedural Kits: Demand for integrated packs containing the stent, pusher (open/closed end), nitinol hydrophilic guidewire, and position markers.
  • Supply Chain Risk Mitigation: Israeli importers are diversifying supply routes beyond Europe, seeking direct partnership with tier-1 Chinese manufacturers possessing robust quality systems and fast sea/air logistics to Haifa and Ashdod ports.
Manufacturer Credentials

Why Partner With Our Manufacturing Base?

Operating out of our advanced industrial medical complex since 1988, our enterprise (Shree Umiya Surgical / Mediplus) combines over 36 years of precision polymer processing with complete clean-room vertical integration.

We perform raw material inspection, precision extrusion, tip forming, hole punching, hydrophilic coating deposition, blister packaging, and EO chamber sterilization entirely in-house. This single-source control eliminates quality variations, guarantees lot-to-lot consistency, and enables competitive pricing models for Israeli medical tenders.

Frequently Asked Questions by Israeli Medical Buyers & Importers

Practical answers regarding technical specs, AMAR registration documentation, minimum order quantities (MOQ), and logistical lead times for Israeli ports.

Do your Double J Stents hold CE MDR and ISO 13485 certification for Israeli AMAR registration?
Yes. All our urological stents and catheter product lines are manufactured under ISO 13485:2016 certified Quality Management Systems and hold valid CE mark certifications under European Medical Device Regulations. Our regulatory department provides full Technical Files, Biocompatibility Reports (ISO 10993), Free Sale Certificates (FSC), and Sterilization Validation Summaries required by the Israeli Ministry of Health (AMAR) for seamless importer registration.
What sizing configurations and kit options are available for hospital supply?
We manufacture a comprehensive spectrum of sizes: Charrière/French diameters ranging from 3.0 Fr, 4.7 Fr, 5.0 Fr, 6.0 Fr, 7.0 Fr, to 8.0 Fr, with lengths spanning 10 cm to 30 cm. Options include Open-Open or Open-Closed distal/proximal end configurations, single or double pigtails, with or without drainage side holes, and optional withdrawal sutures. Stents can be ordered individually in sterile pouches or as complete Ureteral Stent Sets co-packaged with positioners and Nitinol/PTFE guidewires.
What is the shelf life and sterilization protocol for export shipments to Israel?
Our products undergo validated Ethylene Oxide (EO) sterilization in accordance with EN ISO 11135 standards. Packaged in medical-grade Tyvek/Film peel pouches, our Double J Stents carry a validated 5-year sterile shelf life. Every export consignment is released with a Certificate of Analysis (CoA) and EO sterilization release documentation.
What are the minimum order quantities (MOQ) and delivery times to Ashdod or Haifa ports?
For standard OEM packaging, our MOQ starts at 1,000 units per size, or mixed SKU container loads for regional distributors. Standard lead time from order confirmation to port dispatch is typically 3 to 4 weeks. We ship via ocean freight directly to Haifa Port or Ashdod Port, as well as expedited air freight to Ben Gurion International Airport (TLV) for urgent hospital tender deliveries.
Can you provide OEM private-label packaging with dual Hebrew/English artwork?
Absolutely. We offer complete private-label OEM manufacturing for Israeli medical device distributors. Our packaging design team assists in customizing inner Tyvek pouches, outer boxes, master cartons, and Instructions for Use (IFU) with dual Hebrew/English text, UDI barcode integration, and buyer-specific trade names.

Partner with China’s Leading Double J Stent Manufacturer

Looking to elevate your urological product portfolio, participate in Israeli HMO tenders, or secure high-margin OEM manufacturing? Contact our global export team today for technical data sheets, sample evaluation kits, and factory-direct quotation pricing.

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