Engineered for trauma-free urethral insertion, precise balloon symmetry, and strict infection control. Produced in Class 10,000 cleanrooms and exported to healthcare distributors in 52+ countries worldwide.
100% batch-tested under hydro-burst and pressure retention protocols to prevent deflation or uneven expansion inside the urinary bladder.
Processed in captive Ethylene Oxide chambers achieving SAL 10⁻⁶ sterility level with fully validated residual gas aeration cycles.
Supported by Technical Files, Biocompatibility Reports (ISO 10993), Free Sale Certificates (FSC), and CE MDR compliance data.
Medical device importers, hospital purchasing syndicates, and OEM brand managers face tightening regulatory frameworks, increased emphasis on Catheter-Associated Urinary Tract Infection (CAUTI) reduction, and supply chain resilience demands. Sourcing the ideal Foley Balloon Catheter requires evaluating polymer biocompatibility, lumen architecture, inflation valve durability, and factory-level auditing capabilities.
As healthcare systems prioritize patient safety and hospital cost-efficiency, the demand for high-spec indwelling urinary catheters has shifted dramatically toward 100% Medical Grade Silicone and Hydrophilic Polymer Coated Latex Catheters. Procurement managers must look beyond unit cost to consider long-term clinical performance, tissue irritation indices, and batch-to-batch consistency.
At Angiplast Pvt. Ltd., we bring over three decades of medical device manufacturing experience to the urology sector. From our integrated facility in India, we engineer 2-Way and 3-Way Foley Catheters that address core clinical challenges: mucosal trauma during catheterization, encrustation, lumen collapse, and accidental balloon deflation. This technical buyer guide provides an empirical breakdown of product specifications, future procurement vectors, manufacturing processes, and regulatory requirements necessary for institutional tenders and private-label contract manufacturing.
Class 10,000 Cleanroom Certified Angiplast manufactures a complete portfolio of indwelling urethral catheters engineered for pediatric, adult, short-term, long-term, and post-operative surgical applications.
Constructed from natural medical-grade latex coated with a smooth silicone elastomer layer. The silicone surface reduces urethral friction and minimizes tissue reaction, making it the cost-effective standard for routine short-term drainage (up to 14 days).
Manufactured entirely from translucent, biocompatible medical silicone. Inert, bio-stable material reduces encrustation and biofilm build-up, ideal for long-term catheterization (up to 30 days) and latex-sensitive patients.
Equipped with a third dedicated lumen for continuous bladder irrigation (CBI). Essential post-prostatectomy or TURP surgical procedures to flush out blood clots, fibrin debris, and prevent postoperative urinary blockage.
Specially calibrated ultra-fine French sizes designed for pediatric and neonatal urology care. Features a pre-inserted nylon stylet to supply longitudinal stability during difficult juvenile urethral placement.
Dual-function urinary catheter integrated with a high-precision thermistor sensor near the tip. Provides continuous core body temperature measurement while performing routine urinary bladder drainage during critical care and surgical procedures.
Features a slightly curved, tapered distal tip designed to navigate past urethral strictures, enlarged prostates (BPH), and false passages. Provides urologists with enhanced directional control during catheterization.
| French Size (Charrière) | Outer Diameter (mm) | Color Code Standard | Balloon Capacity (ml / cc) | Catheter Length (mm) | Primary Clinical Application |
|---|---|---|---|---|---|
| 6 Fr | 2.0 mm | Green | 1.5 – 3 ml | 270 mm | Pediatric / Neonatal Urology |
| 8 Fr | 2.7 mm | Blue | 3 – 5 ml | 270 mm | Pediatric Inpatient Care |
| 10 Fr | 3.3 mm | Grey | 3 – 5 ml | 300 mm / 400 mm | Paediatric / Adolescent Care |
| 12 Fr | 4.0 mm | White | 5 – 10 ml / 30 ml | 400 mm | Adult Female / Narrow Urethra |
| 14 Fr | 4.7 mm | Green | 5 – 10 ml / 30 ml | 400 mm | Standard Adult Male / Female |
| 16 Fr | 5.3 mm | Orange | 5 – 10 ml / 30 ml | 400 mm | Standard Adult Routine Drainage |
| 18 Fr | 6.0 mm | Red | 10 ml / 30 ml | 400 mm | Adult High Flow / Hematuria |
| 20 Fr | 6.7 mm | Yellow / Violet | 30 ml | 400 mm | Heavy Debris / Post-Op Drainage |
| 22 Fr – 24 Fr | 7.3 – 8.0 mm | Purple / Blue-Dark | 30 – 50 ml | 400 mm | Continuous Bladder Irrigation (3-Way) |
Understanding where the global urinary catheter market is moving empowers procurement directors to choose products that reduce hospital stay durations, withstand regulatory audits, and prevent costly CAUTI complications.
While silicone-coated latex catheters remain popular in price-sensitive government health systems, global procurement data points toward a fast-growing shift toward 100% liquid silicone rubber (LSR) Foley catheters. Driving factors include:
Healthcare-Associated Infections (HAIs), specifically CAUTIs, account for over 30% of total hospital-acquired conditions worldwide. Modern catheter development focuses heavily on surface engineering:
Angiplast Private Limited (established 1994 in Ahmedabad, India) operates fully integrated, state-of-the-art polymer processing facilities certified to ISO 13485 standards.
Our facility utilizes high-precision extrusion machinery and computerized liquid silicone moulding (LSR) systems, guaranteeing exact lumen concentricity, smooth lateral eyes, and uniform wall thickness.
Catheter assembly, tipping, side-hole punching, and pouch packaging are conducted inside environmental controls to minimize initial particulate load and bioburden levels.
Our captive Ethylene Oxide (ETO) sterilizer runs validated gas concentration, humidity, and temperature profiles (ISO 11135), delivering a guaranteed Sterility Assurance Level (SAL) of 10⁻⁶.
Every lot undergoes stringent mechanical testing: balloon burst pressure, inflation/deflation volume retention, tensile strength of joint bond, lumen flow rate, and ETO residual gas analysis.
We offer customized primary blister pouches, rigid trays, shelf cartons, multilingual Instructions for Use (IFU), and direct Unique Device Identification (UDI) barcoding for international tenders.
Over 80% of our production volume is exported overseas. We maintain robust regulatory files (CE, Free Sale Certificates, FDA 510(k) clearances) to streamline local importer registrations.
In-depth technical and commercial answers addressing common inquiries from hospital tender committees, medical device distributors, and private-label buyers.
Angiplast provides a complete technical dossier required by national medical device regulatory agencies (such as US FDA, EU MDR, ANVISA, SFDA, and MOH). Our registration packet includes:
The primary structural difference lies in the number of internal lumens within the catheter shaft:
100% Medical Grade Silicone is an inert polymer offering distinct clinical benefits over latex:
Balloon failure causes catheter displacement or severe bladder trauma. Angiplast enforces strict quality control steps:
Our OEM minimum order quantity typically starts at 10,000 units per individual SKU/French size for private label blister packing. We provide complete branding customization, including direct pouch printing, custom carton box artwork, UDI barcode generation, and multi-language IFUs. Production lead time for standard repeat export orders is typically 3 to 4 weeks after artwork approval.
Angiplast supplies Foley catheters in medical-grade Tyvek-to-film peel pouches or Paper-to-Film peel packs designed to maintain sterile barrier integrity. All standard Foley catheters carry a 5-year sterile shelf life from the date of ETO sterilization, backed by real-time and accelerated aging validation data.
Angiplast adheres strictly to international ISO standards (ISO 20696) for color-coding catheter inflation valve funnels. This prevents accidental size selection errors in emergency and operating rooms (e.g., Green = 6 Fr & 14 Fr, Blue = 8 Fr, Grey = 10 Fr, White = 12 Fr, Orange = 16 Fr, Red = 18 Fr, Yellow = 20 Fr, Violet/Purple = 22 Fr/24 Fr).
Yes. Over 80% of our production is exported globally. Our export logistics desk regularly consolidates Foley catheters with complementary urology disposables (such as Urine Collection Bags, Urinemeters, Nelaton Catheters) and other medical disposables (IV Cannula, Infusion Sets) into single 20ft or 40ft High Cube containers, significantly reducing landed shipping costs per unit for our importers.
Combining 30+ years of medical device engineering expertise with scalable India-based manufacturing excellence.
Unlike suppliers who outsource critical manufacturing stages, Angiplast maintains 100% control over the supply chain: from medical grade polymer compound selection, tooling design, and automated injection moulding to cleanroom packaging, ETO sterilization, and quality release testing.
This vertical integration ensures complete lot-to-lot consistency, full material traceability, competitive factory-direct pricing, and flexible response times for custom OEM developments.
Connect directly with our export engineering desk to request technical samples, factory audit files, or custom OEM quotation terms.
