Precision single-use IV infusion sets, microdrip sets, DEHP-free tubing, and light-resistant lines manufactured in ISO Class 7/8 cleanrooms in Ahmedabad, India.
Engineered for clinical safety with 15µm fluid filters, needle-free Y-sites, auto-prime air vents, and non-DEHP plasticized polymers.
Ethylene Oxide (EO) validated sterilization, continuous flow rate testing, and full MDR technical files for international registration.
Direct export supply chains, localized regulatory dossiers, and competitive OEM contract manufacturing from India since 1988.
For hospital purchasing agents, medical device importers, and tender committees, selecting a compliant Medical Infusion Set requires an understanding of fluid dynamics, polymer biocompatibility, and international standards. A high-performance IV set must deliver precise drop calibration, maintain zero leakage under hydraulic pressure, prevent particulate contamination, and minimize drug absorption.
At Mediplus (Shree Umiya Surgical Pvt. Ltd.), our infusion sets are engineered and tested in accordance with ISO 8536-4 (Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed). The key mechanical requirements governing our production lines include:
Traps micro-particles & crystallized solutes per ISO 8536-4.
Cold-flow resistant roller clamp prevents tube deformation.
TOTM / DINCH options prevent chemical leaching into lipid solutions.
Luer-activated swabable Y-sites prevent needle-stick injury.
Mediplus offers a full spectrum of single-use IV infusion sets designed for general fluid replacement, pediatric intensive care, oncology therapeutics, and rapid transfusion protocols.
Available with sharp ABS spike, flexible transparent drip chamber with 15µm filter, precision roller clamp, self-sealing latex/latex-free injection site, and rotating male luer lock. Ideal for routine gravity fluid replacement.
Featuring a 60 drops/mL stainless steel drop tube inside a clear chamber, allowing precise titration of critical medications, pediatric fluids, and low-volume anesthetic agents. Equipped with micro-roller clamp for fine adjustment.
100 mL and 150 mL calibrated clear cylinders with auto shut-off floating valve to prevent air embolism. Includes a 60 drops/mL micro-drip orifice, air vent with hydrophobic filter, and secondary injection ports.
Formulated with opaque UV-blocking yellow or amber polymers that prevent photolytic degradation of light-sensitive parenteral drugs such as sodium nitroprusside, chemotherapy agents, and multivitamin infusions (290–450nm light wave protection).
Manufactured using non-phthalate plasticizers (TOTM/DINCH) or medical-grade Thermoplastic Polyurethane (TPU). Eliminates plasticizer leaching during lipid emulsion administration, paclitaxel delivery, and neonatal intensive care infusion.
Integrated with split-septum or mechanical valve needle-free connectors. Eliminates needle-stick injuries for clinical personnel while offering a swabable surface that withstands multiple access cycles without microbial ingress.
Compare technical configurations across the Mediplus Medical Infusion Set product family for OEM procurement planning:
| Infusion Set Variant | Drip Rate | Filter Pore Size | Spike Air Vent | Tubing Material | Injection Site | Luer Fitting |
|---|---|---|---|---|---|---|
| Standard Gravity Set (Vented) | 20 drops/mL | 15 µm disc | Hydrophobic air filter | Medical Grade PVC (K-70) | Latex Bulb / Latex-Free Flashball | Rotating Male Luer Lock |
| Standard Non-Vented Set | 20 drops/mL | 15 µm disc | Non-vented spike | Flexible PVC / DEHP-Free | Self-Sealing Y-Site | Luer Lock / Luer Slip |
| Microdrip Precision Set | 60 drops/mL | 15 µm disc | Vented with cap | Medical Grade PVC / TPU | Needle-Free Valve / Latex-Free | Rotating Male Luer Lock |
| Measured Volume Burette Set | 60 drops/mL | 15 µm disc | Vented (100ml / 150ml) | Kink-Resistant PVC / DEHP-Free | Multiple Y-Ports + Floating Valve | Luer Lock with Cap |
| Light-Protected Amber Line | 20 or 60 drops/mL | 15 µm disc | Vented / Non-vented | UV-Blocking Polymeric Compound | Swabable Needle-Free Y-Port | Male Luer Lock |
| Oncology & Neonatal TPU Set | 20 or 60 drops/mL | 15 µm disc | Vented with filter | 100% Polyurethane (PVC-Free) | Split-Septum Needle-Free Valve | Rotating Male Luer Lock |
The global infusion therapy landscape is undergoing significant regulatory, environmental, and clinical transformations. Supply chain managers and procurement officers must align their sourcing strategies with upcoming international standards and technological advancements.
Regulatory authorities, including the European Medicines Agency (EMA) under EU MDR Annex I and health ministries across North America and East Asia, are restricting Di(2-ethylhexyl) phthalate (DEHP) in single-use medical devices. Future procurement is moving toward DEHP-Free PVC (utilizing TOTM or DINCH plasticizers) and total PVC-Free Polyurethane (TPU) infusion sets to protect neonates, oncology patients, and long-term ICU admissions from endocrine disruption and chemical leaching.
Nosocomial infections and hospital-acquired bloodstream infections (HA-BSIs) have led to strict clinical guidelines penalizing open-system IV sets. Modern hospital tenders require closed-system infusion sets integrated with swabable needle-free connectors and anti-siphon back-check valves. These components eliminate needle-stick injuries among healthcare personnel while maintaining a sterile microbial barrier through multiple medication access cycles.
Global Healthcare Group Purchasing Organizations (GPOs) are evaluating suppliers based on environmental footprint metrics. Eco-conscious manufacturing involves reducing plastic mass per set, removing heavy metals from colorants, utilizing recyclable Tyvek pouch materials, and powering cleanroom extrusion lines via renewable energy sources (such as Mediplus’s rooftop solar power plant).
The concentration of medical disposable manufacturing in single regions exposed global healthcare systems to severe supply chain bottlenecks during past global disruptions. International procurement teams are actively establishing dual-sourcing partnerships with established Indian manufacturers like Mediplus (Shree Umiya Surgical Pvt. Ltd.), benefiting from high regulatory compliance, tariff advantages, and reliable port logistics via Mundra and Nhava Sheva.
Quality cannot be inspected into a medical disposable; it must be built into the manufacturing architecture. Mediplus operates a fully vertically integrated manufacturing facility in Vatva, Ahmedabad, controlling every stage of Medical Infusion Set production.
With over 36 years of specialized manufacturing experience, Mediplus provides international hospital distributors and OEM partners with unmatched reliability, documentation, and cost efficiency.
Established in 1988 in Ahmedabad, India, our facility has delivered millions of single-use medical devices globally, establishing a reputation for zero-recollection quality consistency.
Our in-house regulatory team provides complete Technical Files, Common Technical Documents (CTD), Free Sale Certificates (FSC), ISO 13485:2016 QMS dossiers, and CE documentation for Ministry of Health registrations.
We offer full OEM contract manufacturing: buyer-specified drip rates, custom tube lengths, color-coded clamps, private-label packaging artwork, multilingual IFUs, and UDI barcoding.
Direct export management from Mundra and Nhava Sheva ports. High-density master carton designs minimize freight volume, lowering landed per-unit transport costs for overseas importers.
Detailed technical, regulatory, and commercial answers for hospital procurement specialists, import agents, and biomedical engineers.
Mediplus Medical Infusion Sets are manufactured under an ISO 13485:2016 and ISO 9001 certified Quality Management System. The infusion sets comply strictly with ISO 8536-4 (Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed), ISO 10993 (Biological Evaluation of Medical Devices), ISO 11135 (Sterilization of health-care products — Ethylene oxide), and EU MDR 2017/745 regulatory guidelines. Batch-specific Certificates of Analysis (CoA), sterilisation release certificates, and bioburden test reports accompany every export shipment.
The choice between vented and non-vented infusion sets depends on the IV fluid container material:
DEHP [Di(2-ethylhexyl)phthalate] is a traditional plasticizer used to make PVC flexible. However, lipophilic drugs (such as paclitaxel, chemotherapy drugs, and lipid emulsions) can leach DEHP from the tubing into the patient's bloodstream, posing health risks to high-sensitivity cohorts. Furthermore, PVC can absorb certain active drug compounds onto the tubing wall, reducing dosage delivery accuracy. DEHP-Free (using TOTM/DINCH) or TPU (Thermoplastic Polyurethane) infusion sets eliminate chemical leaching and drug absorption, ensuring patient safety in neonatology, pediatrics, oncology, and intensive care units.
Flow rate decay (or "tube creep") occurs when PVC tubing permanently deforms under the pressure of a roller clamp over time, leading to reduced fluid delivery rates. Mediplus solves this by using high-resilience, memory-retentive medical polymers for tube extrusion and high-rigidity ABS roller clamps. Our sets undergo cold-flow resistance testing, maintaining flow rate accuracy within ±5% to ±10% of nominal settings over a 24-hour continuous gravity feed period.
Yes. Our dedicated Regulatory Affairs department assists global importers and tender agents with complete technical registration dossiers. We provide Free Sale Certificates (FSC), ISO 13485 & CE certificates, technical files in Common Technical Document (CTD) format, biocompatibility test summaries (ISO 10993-3/5/10/11), stability test data, packaging validation studies, and legalised/apostilled documentation required by Ministries of Health across Latin America, the Middle East, Africa, CIS, and Southeast Asia.
We provide full private label and OEM customization for hospital brands and international medical distributors, including:
For standard Mediplus catalog products, the minimum order quantity starts at 10,000 units (or 1 pallet per SKU). Private label OEM orders typically require a minimum of 50,000 units or a mixed 20-foot container load. Standard production lead time is 3 to 4 weeks following artwork approval. Shipments are dispatched via Mundra Port or Nhava Sheva Port, India, under FOB, CIF, or CFR freight terms.
Partner with India’s leading medical disposable exporter. Contact our international sales engineering team for technical datasheets, factory audits, or competitive container-load pricing.
Seven clinical ranges, 400+ single-use device SKUs.
Catalogue, product sheets and certificate references.
Recognitions, approvals and export milestones.
Technical, regulatory and after-sales assistance.