Engineered for surgical excellence, urological care, and critical drainage protocols serving medical importers and hospital networks in Nagoya.
Precision-engineered multi-lumen central venous catheter set for vascular access, critical fluid delivery, and central venous pressure monitoring in intensive care units.
High-grade German stainless steel trocar cannula designed for veterinary surgical interventions, featuring custom ergonomic grips and sterilizable integrity.
Innovative stainless steel laparoscopic trocar cannula assemblies engineered for precise puncture performance and durable repetitive clinical sterilization.
Advanced puncture trocar cannula crafted to offer smooth tissue entry, low insertion force, and high burst-pressure lumen seal containment.
Sterile thoracic trocar catheters designed for rapid chest drainage, featuring radio-opaque lines and tapered bevel tips for atraumatic pleural penetration.
Specialized bent tubing catheter assemblies optimized for endoscopic ENT interventions, offering consistent flexibility and kink-resistant fluid clearance.
Single-use 5mm bladeless trocar cannula providing minimal abdominal wall trauma, optical clarity, and zero leak abdominal gas retention during laparoscopy.
Sterile laparoscopic trocar with auto-retracting protective blade shield designed for emergency clinical laparoscopy and minimally invasive surgery.
The healthcare infrastructure of Nagoya City and the broader Aichi Prefecture represents one of East Asia’s most sophisticated acute-care and geriatric clinical ecosystems. Encompassing world-class medical centers such as Nagoya University Hospital, Aichi Cancer Center, Nagoya City University Hospital, and Chubu Medical Center, the region demands an uninterrupted, highly reliable supply of premium, sterile urinary management disposables—chiefly Foley Balloon Catheters.
As a global OEM/ODM manufacturer and exporter of medical disposables operating under strict international regulatory frameworks, Sterimed Group (established 1955) delivers high-precision urological catheters engineered specifically to satisfy the stringent quality standards mandated by Japanese importers, medical device distributors, and hospital procurement boards. By synthesizing advanced polymer elastomer science with sterile cleanroom manufacturing, our Foley catheter solutions provide superior patient comfort, eliminate catheter-associated urinary tract infection (CAUTI) risk factors, and ensure frictionless compliance with Japan’s Pharmaceuticals and Medical Devices Act (PMDA) expectations.
Understanding the engineering breakthroughs behind high-performance 2-Way and 3-Way Foley balloon catheters.
Our catheters utilize medical-grade platinum-cured silicone or ultra-smooth silicone-coated natural rubber latex. The inert silicone barrier prevents tissue encrustation, minimizes urethral irritation, and reduces protein adherence, making it ideal for long-term indwelling use (>30 days).
Precision concentric wall moulding guarantees 100% symmetrical balloon expansion upon sterile water inflation (5ml to 30ml capacities). Symmetrical anchoring prevents bladder neck asymmetry, trauma, micro-lesions, and involuntary catheter ejection during patient movement.
Calculated internal luminal cross-sections (applying Poiseuille’s fluid resistance principles) maximize drainage flow rates while preventing debris clogging. 3-Way irrigation variants feature dedicated continuous bladder irrigation (CBI) channels for urological surgery recovery.
Comprehensive technical data for medical device importers, hospital purchasing committees, and clinical evaluators.
| Catheter Type | French Size Range (Charrière) | Balloon Capacity (ml) | Material Composition | Key Clinical Features | Sterilization Method |
|---|---|---|---|---|---|
| 2-Way Paediatric Foley | Fr 06 – Fr 10 | 3 ml – 5 ml | 100% Medical Silicone / Silicone-Coated Latex | Atraumatic round tip, short length, sleeve wire insert option | Ethylene Oxide (EO) / ISO 11135 |
| 2-Way Standard Adult | Fr 12 – Fr 26 | 5 ml – 30 ml | 100% Translucent Silicone / Siliconised Latex | Symmetrical balloon, smooth bevelled drainage eyes, radiopaque strip | Ethylene Oxide (EO) / ISO 11135 |
| 3-Way Hematuria / Irrigation | Fr 16 – Fr 30 | 30 ml – 50 ml | High-Durometer Reinforced Silicone | Large irrigation lumen for postoperative bladder instillation & clot evacuation | Ethylene Oxide (EO) / ISO 11135 |
| Hydrophilic Coated Foley | Fr 12 – Fr 24 | 10 ml – 30 ml | Polymer-Coated Non-Thrombogenic Silicone | Ultra-low friction coefficient upon hydration; virtually zero insertion trauma | Ethylene Oxide (EO) / ISO 11135 |
Aichi Prefecture is at the forefront of Japan’s demographic shift, characterized by an expanding senior population requiring prolonged home care, long-term care facility admission, and specialized urological care. Key market forces shaping Foley catheter procurement in Nagoya include:
Customized product utility matching specific clinical pathways in regional healthcare institutions.
In major surgical suites performing cardiovascular or abdominal procedures, accurate hourly urine output monitoring is critical. Our 2-way silicone catheters paired with precision closed-system urometers guarantee leak-free drainage and exact measurement under general anesthesia.
Post-TURP (Transurethral Resection of the Prostate) and bladder tumor resections require continuous fluid instillation. Sterimed 3-way Fr 20–24 catheters feature high-strength non-collapsible irrigation lumens to flush out blood clots and prevent hematuria blockages.
For bedridden elderly patients suffering from chronic neurogenic bladder dysfunction, 100% silicone hydro-coated catheters provide maximum tissue biocompatibility, allowing extended indwelling intervals without encrustation or urethral stricture.
Over six decades of manufacturing heritage, state-of-the-art cleanrooms, and robust global supply chains.
Sterimed Group operates certified ISO Class 7 and Class 8 controlled cleanrooms. From raw polymer compounding, precision tube extrusion, and automated balloon dipping to validated Ethylene Oxide (EO) sterilization, every single step is executed under one roof to maintain total lot-to-lot consistency.
We offer comprehensive OEM capabilities tailored to Japanese market distributors. This includes customized medical-grade pouch printing, dual-language IFUs (Japanese/English), customized primary carton packaging, and specialized inner tray configurations.
Our plants operate strictly under ISO 13485:2016 and ISO 9001 Quality Management Systems. We hold WHO-GMP certification and full CE Mark technical documentation, empowering importers to submit seamless regulatory dossiers to authorities world-wide.
Our international export desk manages full container loads (FCL) and less-than-container loads (LCL) directly to the Port of Nagoya (NUCT terminals) or via express air freight to Chubu Centrair International Airport (NGO), ensuring steady shelf stock for distributors.
Direct answers regarding regulatory compliance, quality control, shipping, and technical specifications.
Yes. Sterimed prepares comprehensive technical files aligned with STED (Summary Technical Documentation) requirements. We supply raw material biocompatibility test data (ISO 10993 cytotoxicity, sensitization, systemic toxicity), EO residual analysis reports, and sterility assurance level (SAL 10⁻⁶) data required by Japanese importers for PMDA filing.
100% liquid silicone rubber (LSR) catheters are completely latex-free, eliminating Type I latex allergy risks in sensitive patients. Furthermore, full silicone catheters feature wider lumen inner diameters (yielding superior flow rates) and higher resistance to encrustation, making them the preferred standard for acute care hospitals in Nagoya.
All catheters are terminally sterilized using Ethylene Oxide (EO) gas in ISO 11135-compliant chambers. Each production batch undergoes rigorous biological indicator incubation, EO residual gas chromatography testing, chemical indicator color verification, and mechanical balloon burst/inflation testing before release.
Standard production lead times range between 2 to 4 weeks depending on order volume and custom OEM packaging requirements. Direct sea shipping from major ports to Nagoya Port typically takes 14 to 20 days. Emergency clinical shipments can be dispatched via air freight to Chubu Centrair International Airport (NGO).
Absolutely. Our packaging cell supports private label OEM branding, including localized Japanese Instructions for Use (IFU), GS1-128 or QR barcode printing, custom batch numbering, and importer notification details printed directly onto individual blister pouches and master export cartons.
Authorized medical device distributors, hospital purchasing managers, and import agents can request sterile product evaluation samples by clicking the "Get Catalog" button on this page to connect directly with our international export documentation desk.
Elevate your medical device portfolio in Nagoya and Aichi Prefecture with ISO 13485 certified, CE-marked, and clinically validated urological disposables from Sterimed Group.