Engineered for clinical precision, bio-compatibility, and hydro-dynamically efficient vascular access. Available for global distributor branding and custom contract manufacturing.
Why leading healthcare brands, dialysis networks, and tender procurement desks partner with our manufacturing facility.
Operates under audited Quality Management Systems meeting ISO 13485:2016 and ISO 9001 standards. Fully documented CE technical dossiers ready for international MoH registration.
Full private-label customisation including multi-lumen geometric configuration, tip profiles, Hub coloration, customized kit assembly, and multilingual packaging artwork.
Utilization of thermosensitive medical-grade Thermoplastic Polyurethane (TPU) and bio-inert Platinum-Cured Silicone that softens at body temperature to minimize trauma.
Direct manufacturer pricing backed by high-capacity automated production lines in Ahmedabad, India, ensuring competitive landed costs for large importers.
100% in-house EtO (Ethylene Oxide) and Gamma Irradiation processing adhering to ISO 11135 standards with biological indicator tracking and residual EO testing.
Every single catheter kit is 100% traceable from raw resin lot, extrusion line, cleanroom molding shift down to final bioburden verification.
In modern critical care, nephrology, and oncology units, central venous access devices—ranging from short-term Central Venous Catheters (CVC) to long-term tunneled cuffed hemodialysis catheters—represent vital lifelines for therapeutic delivery and extracorporeal blood purification. Selecting a contract manufacturing partner requires deep scrutiny of polymer performance, hydrodynamic lumen design, and strict regulatory compliance.
Industry Insight: The global central venous catheter market is transitioning rapidly toward thermosensitive polymers and micro-engineered lumen geometries that minimize vessel wall trauma, bacterial adhesion, and recirculation rates during hemodialysis treatment.
The selection of raw materials dictates a catheter’s mechanical integrity, kink resistance, and biocompatibility profile. OEM buyers must evaluate two primary polymer formulations based on clinical intent:
Advanced aromatic and aliphatic TPUs are widely specified for acute central venous access and short-to-medium-term hemodialysis. Polyurethane offers exceptional tensile strength, permitting thinner lumen walls with larger internal cross-sectional areas. This translates directly into superior flow rates at lower pump pressure gradients. Crucially, modern medical-grade TPU exhibits thermosensitive softening properties: firm at ambient temperature during catheter insertion, it softens significantly upon reaching physiological body temperature (37°C), decreasing vessel wall friction and risk of phlebitis.
For long-term tunneled hemodialysis access, platinum-cured liquid silicone rubber (LSR) remains the gold standard. Silicone maintains unparalleled flexibility, chemical inertness, and resistance to degradation caused by repeated exposure to alcohol-based site dressings and lock solutions. Integrated tissue-ingrowth cuffs (Dacron) bonded to silicone shafts promote fibroblast anchoring within subcutaneous tunnels, creating an effective biological barrier against ascending extraluminal bacterial colonization.
Effective extracorporeal blood flow (ranging from 300 to 450 mL/min in adult hemodialysis) demands careful fluid-dynamic engineering. High shear stress leads to hemolysis and platelet activation, accelerating intraluminal thrombus formation.
Our OEM manufacturing lines leverage precision extrusion technology to manufacture diverse lumen geometries:
| Parameters | Standard CVC / HD Catheter Kits | Customized OEM / Private-Label Solution |
|---|---|---|
| Lumen Configurations | Single, Double, Triple Lumen (7Fr, 12Fr, 14Fr, 15Fr) | Custom Fr sizes (5Fr to 16Fr), specialized lumen wall thickness |
| Substrate Material | Standard Medical Polyurethane / Silicone | Thermosensitive Aliphatic TPU or Platinum-Cured Silicone |
| Tissue Ingrowth Cuff | Standard Polyester / Dacron Cuff | Customized cuff placement distance, anti-microbial silver coating options |
| Sterilization Method | Ethylene Oxide (EtO) Batch Process | Validated EtO or Gamma Irradiation with custom SAL 10^-6 release |
| Kitting & Accessories | Standard Guidewire, Dilator, Introducer Needle | Fully customized surgical pack (scalpel, suture, drape, heparin caps) |
| Regulatory Documentation | ISO 13485, CE Mark (MDR) Technical File | Full Technical File Transfer, UDI & Multilingual Packaging Dossier |
The global procurement landscape for single-use vascular access consumables is experiencing structural shifts driven by stringent regulatory frameworks, hospital cost-containment mandates, and technological advancements in infection prevention.
Regulatory authorities worldwide—including the European Medicines Agency (MDR), US FDA, and Saudi Food and Drug Authority (SFDA)—have elevated documentation and clinical evaluation standards for Class IIa, IIb, and Class III medical devices. Medical device brand owners and importers are actively migrating away from non-certified factories toward robust contract manufacturers that maintain up-to-date Technical Documentation, ISO 10993 Biocompatibility test suites, and ongoing Post-Market Surveillance (PMS) data.
Catheter-Related Bloodstream Infections (CRBSI) and catheter-related thrombosis represent significant clinical costs for healthcare systems. As a result, global procurement desks are seeking OEM partners capable of applying specialized surface treatments—such as hydrophilic lubricious coatings, heparin-grafted antithrombotic surfaces, and micro-encapsulated antimicrobial agents—to decrease bacterial adhesion and biofilm establishment.
To guard against supply chain vulnerabilities, hospital networks, renal dialysis service groups, and national health ministries are forming direct manufacturing partnerships with high-capacity production facilities in India. Manufacturing centers in Gujarat—such as Shree Umiya Surgical Pvt. Ltd. (Mediplus)—provide an optimal synthesis of certified precision manufacturing, cleanroom production capacity, and economic efficiency.
Our Vatva, Ahmedabad plant exemplifies modern green medical manufacturing. Powered by rooftop solar energy installations, the facility integrates granules-to-carton quality control within ISO Class 7 and Class 8 cleanrooms.
Direct oversight over raw material compounding, precision tube extrusion, insert molding, ultrasonic hub welding, and automated EtO sterilization ensures zero compromise on final device sterility and structural performance.
Founded in 1988, Shree Umiya Surgical Pvt. Ltd. (known globally as Mediplus) has grown over three decades into a leading manufacturer and exporter of single-use medical disposable devices. Operating from an extensive manufacturing hub in Ahmedabad, Gujarat, India, Mediplus exports high-precision catheters, vascular access kits, infusion sets, and surgical consumables to over 70 countries worldwide.
Our technical capabilities span across seven core clinical disciplines: Central Venous Access & Dialysis, Infusion & Transfusion, Urology, Anaesthesia, Surgery, Gastroenterology, and General Ward Disposables. By keeping raw-material verification, extrusion, assembly, and sterilization entirely under one roof, we eliminate cross-batch variability and deliver landed-cost advantages directly to global distributors and private-label partners.
Detailed technical responses from our Engineering and Regulatory Affairs teams regarding custom contract manufacturing, private-label packaging, and export logistics.
Our manufacturing plant operates under a Quality Management System certified to ISO 13485:2016 and ISO 9001. Device families hold CE marking under the European Medical Device Regulation (EU MDR) pathway. We supply comprehensive regulatory dossiers including Free Sale Certificates (FSC), Certificates of Analysis (CoA), ISO 10993 Biocompatibility summaries, shelf-life stability data, and legalised documentation for registration with Health Ministries across Europe, Middle East, Latin America, Africa, and Southeast Asia.
We provide end-to-end OEM and private-label programs. OEM clients can specify lumen geometry (Single/Double/Triple), French size (Fr), length, cuff placement, hub color-coding, and custom kit configurations (including dilators, Nitinol guidewires, introducer needles, scalpels, and drapes). Private-label services extend to custom artwork design, multilingual Instructions for Use (IFU), barcode generation, Unique Device Identification (UDI) compliance, and custom carton dimensions.
For standard Mediplus catalog items, MOQ typically begins at one pallet per SKU. Private-label OEM contracts usually start at a minimum order volume of one mixed 20-foot container. Standard catalog reorders ship within 3 to 4 weeks following order confirmation. New OEM private-label projects requiring custom packaging tooling or regulatory registration typically take 6 to 8 weeks from final artwork approval.
Single-use devices are sterilized using Ethylene Oxide (EtO) gas or Gamma Irradiation depending on biomaterial stability. Sterilization processes are validated in accordance with ISO 11135 (EtO) to guarantee a Sterility Assurance Level (SAL) of 10^-6. Every production cycle is released only after passing chemical indicator checks, biological indicator incubation (Bacillus atrophaeus), bioburden analysis, and residual EtO limit tests (ISO 10993-7).
Yes. Our in-house tooling room and R&D division work directly with medical device brands to develop custom extrusion dies, tip-forming fixtures, and hub injection molds. Initial CAD proofing and prototype samples are typically generated within 14 working days for customer bench testing prior to pilot cleanroom production.
Export orders ship primarily via Mundra Port and Nhava Sheva (JNPT) Port in India, providing direct maritime connections to global hub ports. We support standard Incoterms including FOB, CIF, CFR, and EXW, with dedicated export logisticians handling customs documentation, bill of lading generation, and container space optimization to minimize unit freight costs.
Looking for a reliable OEM/ODM factory for central venous catheters, dialysis sets, or customized vascular access kits? Request our complete technical catalog, sample packs, or direct factory quotation today.