Engineered to international standards for critical care nephrology, acute dialysis access, and chronic urological management across public and private healthcare sectors in India.
Ergonomically engineered self-adhesive securement device designed to eliminate catheter traction, preventing urethral trauma and accidental displacement during hemodialysis and prolonged urological care.
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Medical-grade 100% silicone 3-way balloon catheter with an integrated irrigation lumen. Ideal for post-urological surgery continuous bladder irrigation and long-term catheterization in nephrology wards.
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Versatile range of silicone catheters available in 2-way, 3-way, and specialized 4-way configurations. Engineered for reduced encrustation risk and optimal flow rate during critical care procedures.
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Complete procedure pack including 3-way catheter, prep tray, lubricated jelly, and drainage components customized for hospital tenders and rapid clinical deployment across Indian medical centers.
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Premium 2-way all-silicone catheter featuring smooth polished eyelets and a durable balloon designed for stable retention and maximum patient comfort during acute nephrological treatments.
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Comprehensive sizing spectrum from pediatric 6Fr up to adult 24Fr. Equipped with color-coded inflation valves for immediate size identification in fast-paced ICU and emergency environments.
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Advanced universal catheter locking mechanism that secures catheter shafts firmly in place, minimizing micro-movement, urethral friction, and risk of catheter-associated urinary tract infections (CAUTI).
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Specially designed pediatric silicone catheter featuring ultra-flexible shaft construction, soft rounded tip, and smooth distal side holes to ensure trauma-free placement in pediatric nephrology units.
Send an InquiryUnderstanding how dialysis catheters and vascular access consumables function across Tier-1 super-specialty hospitals, rural government healthcare schemes, and mobile hemodialysis networks in India.
In high-volume institutions like AIIMS, Fortis, Apollo, and Manipal Hospitals, acute dialysis procedures require high-flow dual-lumen non-tunneled catheter kits (11.5 Fr to 14 Fr) capable of sustaining blood flow rates (Qb) of 300-400 mL/min. OEM/ODM catheter lines manufactured with radiopaque thermo-sensitive polyurethane soften at body temperature, minimizing vessel trauma while maintaining lumen structural integrity during high-pressure pump cycles.
The Pradhan Mantri National Dialysis Programme (PMNDP) has driven an exponential expansion of hemodialysis units in Tier-2 and Tier-3 district hospitals across states like Uttar Pradesh, Maharashtra, Tamil Nadu, and Gujarat. Government procurement demands strict cost-efficiencies paired with CDSCO regulatory compliance. Our OEM/ODM contract manufacturing provides bulk-packaged, sterile catheter kits optimized for high-turnover public dialysis beds.
In intensive care units handling Acute Kidney Injury (AKI) secondary to sepsis, tropical fevers, or multi-organ failure, immediate jugular or femoral central vein catheterization is vital. OEM/ODM femoral catheters with reinforced kink-resistant shafts ensure unobstructed blood flow even when patients undergo bedside Sustained Low-Efficiency Dialysis (SLED) or Continuous Renal Replacement Therapy (CRRT).
As India transitions under the Medical Device Rules (MDR 2017) enforced by CDSCO, medical equipment distributors and hospital supply brands require manufacturing partners who offer comprehensive technical master files (STED), bioburden test protocols, and ETO sterilisation validation.
Deep-dive analysis of clinical shifts, regulatory evolutions, and domestic supply chain transformations shaping the Indian nephrology consumable landscape.
Historically, short-term non-tunneled catheters dominated emergency vascular access in India due to upfront cost sensitivity. However, rising awareness of Catheter-Related Bloodstream Infections (CRBSI) and delayed AV fistula maturation times has triggered a 22% annual surge in demand for silicone/polyurethane tunneled cuffed hemodialysis catheters (TCC) featuring tissue ingrowth Dacron cuffs.
With the Indian Central Drugs Standard Control Organization (CDSCO) reclassifying vascular access catheters under Class C (medium-high risk) and Class D (high risk) medical devices, unorganized importers are facing stringent compliance hurdles. B2B purchasers now mandate ISO 13485:2016 certification, Class 10,000 cleanroom assembly documentation, and biocompatibility testing (ISO 10993 compliant) from their OEM factories.
Government mandates encouraging domestic medical device procurement for public healthcare networks have incentivized top Indian healthcare corporations to partner with established CDMO/OEM factories. By outsourcing specialized catheter extrusion, tip forming, RF printing, and ETO sterilisation to expert factories, brands reduce time-to-market while fulfilling local content requirements.
| Feature / Parameter | Acute Non-Tunneled Catheters | Chronic Tunneled Cuffed Catheters (TCC) | OEM Customization Options |
|---|---|---|---|
| Primary Material | Radiopaque Thermo-sensitive Polyurethane | Carbothane / Medical Grade Silicone | Custom Durometer Shore Hardness |
| Intended Duration | Up to 30 Days (Acute AKI / ICU Access) | Months to Years (Bridge / Permanent Access) | Antimicrobial / Heparin Coating Options |
| French Sizing Range | 6.5 Fr (Pediatric) to 14 Fr (Adult) | 12.5 Fr to 16 Fr High-Flow Lumens | Custom Lengths (12 cm to 36 cm) |
| Recirculation Rate | < 5% at 300 mL/min Qb | < 2% at 400 mL/min Qb | Step-tip, Split-tip, or Symmetric Tip |
| Sterilization Method | Ethylene Oxide (ETO) Sterilization | Ethylene Oxide (ETO) Sterilization | Validated 10^-6 SAL Cycle Verification |
| Target Clinical Hubs in India | District Hospitals, ICU, SLED Units | Metro Dialysis Hubs, Nephrology Institutes | Custom Tender Kit Configurations |
Founded in 1994 in Ahmedabad, Gujarat, Angiplast Private Limited brings over three decades of precision polymer engineering, state-of-the-art cleanroom manufacturing, and comprehensive regulatory support.
From precision microbore tubing extrusion and injection molding of catheter hubs to automated tip forming, eyelet punching, RF printing, and pouch sealing—every process is conducted in-house. This eliminates supply chain friction and ensures strict quality control.
Assembly and kit packing take place within validated Class 10,000 (ISO Class 7) cleanroom environments. Our captive Ethylene Oxide (ETO) sterilisation plant operates with fully validated bioburden, sterility, and ETO residual testing according to ISO 11135 standards.
We provide full-service CDMO support for Indian importers and pharmaceutical brand owners: custom artwork creation, multilingual Instructions for Use (IFU), Unique Device Identification (UDI) barcoding, and complete CDSCO file compilation for smooth registration.
Every lot of hemodialysis and urology catheters manufactured at our plant undergoes rigorous in-house physical, chemical, and biological testing before batch release:
Clear, authoritative answers addressing regulatory registrations, minimum order quantities, custom kit packaging, and logistics for the Indian medical device market.
We provide complete Technical Documentation Packs conforming to CDSCO (Central Drugs Standard Control Organization) Class C/D requirements. This includes Summary Technical Documentation (STED), ISO 13485 certificates, CE declarations of conformity, ISO 10993 biocompatibility reports, ETO sterilisation validation data, and notarized Free Sale Certificates (FSC) to streamline your Indian import license (MD-14/MD-15) application process.
MOQs for OEM and private-label orders depend on the specific catheter family and packaging requirements. Standard production lots usually start at 1,000 to 3,000 units per SKU for standard catheter configurations. For customized tray kits or specialized extrusion dimensions, our CDMO team works closely with partners to accommodate phased pilot production runs.
Yes. We specialize in assembling integrated dialysis and urology catheter insertion kits customized to tender specifications. Kits can include catheter shafts, nitinol guide wires with advancers, introducer needles, vessel dilators, scalpel blades, heparin caps, gauze sponges, and self-adhesive catheter stabilization devices packaged in blister packs or sterile pouches with custom branding.
We utilize premium medical-grade thermo-sensitive polyurethane, Carbothane, and 100% liquid silicone rubber imported from globally recognized polymer suppliers. These materials exhibit thermo-softening properties inside human blood vessels, dramatically lowering vascular endothelial erosion while maintaining structural lumen integrity under high negative pump pressures.
Standard production cycles for established catalog items range between 3 to 4 weeks following design sign-off and PO confirmation. Located in Gujarat, India, our manufacturing complex offers rapid dispatch via inland container depots (ICD) and seamless freight connectivity to major ports (Mundra, Nhava Sheva) and international airports for fast distribution across all Indian states.
Whether you are seeking custom hemodialysis access lines, private-label silicone Foley catheter kits, or high-volume hospital tender manufacturing, our engineering team is ready to discuss your exact technical requirements.
