Anaesthesia & Airway Range
Endotracheal tubes, tracheostomy tubes, venturi masks, and spinal needles.
Engineered for critical care airway management, trauma response, and long-term ventilation. Manufactured in ISO Class 7/8 cleanrooms by Mediplus (Shree Umiya Surgical Pvt. Ltd.).
Thermosensitive PVC formulation, continuous radiopaque line, and atraumatic smooth tip design for maximum mucosal defense.
Strict bioburden testing, residual EO compliance, and batch-by-batch Certificate of Analysis (CoA) for international hospital tenders.
Comprehensive regulatory support including Free Sale Certificates, Technical Files, and UDI barcoding for hospital importers.
Addressing core procurement questions asked by ICU directors, healthcare importers, and Ministry of Health tender boards regarding mechanical integrity, mucosal damage prevention, and bio-flange design.
When hospital purchasing departments, medical device importers, and clinical procurement officers evaluate a Tracheostomy Tube supplier, their technical queries extend far beyond unit price. Modern airway management demands rigorous attention to anatomical compliance, fluid dynamics, tissue trauma reduction, and systemic biocompatibility. A Tracheostomy Tube is a life-sustaining artificial airway surgically inserted into an artificial opening in the trachea to bypass upper airway obstructions, facilitate mechanical ventilation, optimize secretion management, and provide long-term airway access.
At Mediplus (Shree Umiya Surgical Pvt. Ltd.), our manufacturing philosophy is rooted in solving real-world clinical challenges while providing hospital procurement teams with total supply chain clarity. Drawing upon 36+ years of specialized medical extrusion and molding experience at our Vatva, Ahmedabad industrial complex, we produce sterile single-use Tracheostomy Tubes that exceed international quality benchmarks including ISO 13485:2016 and EU MDR directives.
Our Tracheostomy Tubes are manufactured using advanced medical-grade thermosensitive Polyvinyl Chloride (PVC) and biocompatible liquid silicone elastomers. The primary anatomical advantage of thermosensitive PVC is its structural dynamic during insertion and placement:
For mechanically ventilated patients, cuff design determines both ventilation efficiency and patient safety. Mediplus cuffed tracheostomy tubes utilize High-Volume Low-Pressure (HVLP) thin-wall cuffs engineered for optimal sealing dynamics:
Every SKU in our tracheostomy portfolio integrates technical features optimized for ICU, operating room, and homecare ventilation environments:
Explore our complete product lineup tailored for adult critical care, pediatric applications, fenestrated speech rehabilitation, and kink-resistant surgical procedures.
Featuring a High-Volume Low-Pressure cuff, radio-opaque line, obturator, and 15mm connector. Designed for long-term mechanical ventilation in intensive care units.
Engineered for patients off mechanical ventilation, pediatric airway management, or long-term tracheostoma care where aspiration protection is not required.
Incorporates precision fenestration openings in the outer curve to facilitate upper airway airflow, enabling vocalization, speech therapy, and weaning protocols.
Embedded with a stainless steel reinforcing spiral within the lumen wall to deliver maximum collapse-resistance during complex head and neck surgical procedures.
All Mediplus Tracheostomy Tubes include a matched curved obturator with rounded tip for smooth stoma entry.
| Size (ID mm) | Outer Diameter (OD mm) | Length (mm) | Cuff Type Available | Clinical Application |
|---|---|---|---|---|
| 3.0 mm | 4.2 mm | 39 mm | Uncuffed | Neonatal & Pediatric Care |
| 4.0 mm | 5.6 mm | 44 mm | Uncuffed / Micro-Cuff | Pediatric Airway Management |
| 5.0 mm | 6.9 mm | 50 mm | Uncuffed / HVLP Cuffed | Pediatric / Small Adult |
| 6.0 mm | 8.2 mm | 64 mm | HVLP Cuffed / Fenestrated | Adult Critical Care / Weaning |
| 7.0 mm | 9.6 mm | 70 mm | HVLP Cuffed / Fenestrated / Reinforced | Standard Adult ICU Ventilation |
| 7.5 mm | 10.2 mm | 74 mm | HVLP Cuffed / Fenestrated / Reinforced | Standard Adult ICU Ventilation |
| 8.0 mm | 10.9 mm | 76 mm | HVLP Cuffed / Fenestrated / Reinforced | Adult High-Flow Airway Support |
| 8.5 mm | 11.5 mm | 80 mm | HVLP Cuffed / Fenestrated | Adult High-Flow Airway Support |
| 9.0 mm | 12.2 mm | 82 mm | HVLP Cuffed / Uncuffed | Bariatric / Large Anatomy |
| 10.0 mm | 13.5 mm | 86 mm | HVLP Cuffed / Uncuffed | Specialized Surgical / Trauma |
Mediplus manufactures an extensive ecosystem of single-use devices engineered for seamless compatibility in intensive care units and operating theaters.
Endotracheal tubes, tracheostomy tubes, venturi masks, and spinal needles.
Double and triple lumen access catheters with dilator, guidewire, and introducer needle.
DEHP-free kink-resistant IV lines, blood transfusion sets, and safety IV cannulae.
100% silicone and silicone-coated latex 2-way and 3-way urinary catheters.
High-vacuum bellows and drainage catheters for post-operative surgical care.
Medical-grade stainless steel staples for rapid, secure surgical wound closure.
Key shift parameters driving hospital GPO sourcing, regulatory compliance, material safety, and supply chain strategies over the next decade.
Regulatory authorities across the EU, North America, and East Asia are enforcing strict bans on traditional Di(2-ethylhexyl)phthalate (DEHP) plasticizers due to concerns regarding endocrine disruption and leachable plasticizer transfer during prolonged mechanical ventilation. Procurement trends indicate that over 80% of European hospital networks now specify non-phthalate polymer matrices for long-term respiratory contact devices. Mediplus has proactively upgraded its resin compounding technologies, supplying phthalate-free, biocompatible PVC tracheostomy lines that comply fully with REACH and EU MDR 2017/745 Annex I general safety and performance requirements.
Ventilator-Associated Pneumonia (VAP) remains one of the costliest hospital-acquired infections (HAIs) in intensive care units worldwide. Modern clinical protocols strongly advocate for tracheostomy tubes equipped with dedicated subglottic suction lumens positioned directly above the HVLP cuff. This innovation allows continuous or intermittent aspiration of pooled secretions before they can breach the cuff barrier. Hospital procurement buyers are increasingly prioritizing suppliers with advanced multi-lumen co-extrusion capabilities to reduce ICU stays and lower overall patient care expenditures.
Global medical device procurement experienced profound disruptions between 2020 and 2024, exposing vulnerabilities in single-source supply chains. European and Middle Eastern healthcare conglomerates are actively diversifying their sourcing matrix, establishing direct OEM and distributor partnerships with certified Indian medical manufacturers. India's robust chemical infrastructure, skilled engineering workforce, and ISO 13485 cleanroom ecosystems—exemplified by Mediplus's 40,000+ sq. ft. Vatva facility—position Indian exporters as premier strategic partners delivering high quality at competitive landed costs.
Traceability from raw resin to bedside application is no longer optional. Under US FDA GUDID and European EUDAMED regulations, every tracheostomy tube unit box and outer shipper must feature GS1-compliant DataMatrix UDI barcodes. Mediplus integrates automated UDI printing and verification directly into its packaging lines, ensuring global buyers receive fully traceable stock ready for immediate hospital inventory management and regulatory registration.
Established in 1988, Shree Umiya Surgical Pvt. Ltd. (Mediplus India) has grown from a specialized medical molding workshop into a global powerhouse exporting high-precision single-use devices to over 70 countries across Europe, the Middle East, South America, Africa, and Southeast Asia.
Our state-of-the-art manufacturing infrastructure in Vatva, Ahmedabad features state-of-the-art polymer extrusion lines, high-precision injection molding, ISO Class 7 and Class 8 controlled cleanroom assembly zones, and automated Ethylene Oxide (EO) sterilization chambers. Every single Tracheostomy Tube produced undergoes rigorous physical, dimensional, and biological testing to guarantee zero-defect clinical reliability.
By eliminating third-party sub-assembly, Mediplus retains total oversight over material purity, physical tolerances, and sterility assurance levels (SAL 10⁻⁶).
Evaluate sample kits, review technical files, and finalize private-label contracts in person at major medical trade fairs worldwide.
Miami Beach Convention Centre, Miami, USA
Stand No. E-24
Bombay Exhibition Centre, Mumbai, India
Stand No. E-50
Messe Dusseldorf, Germany
Appointments Open
Dubai Exhibition Centre, Dubai, UAE
Appointments OpenAuthoritative technical answers to common queries submitted by global medical distributors, hospital purchasing managers, and regulatory officers.
Mediplus Tracheostomy Tubes are constructed from high-purity, thermosensitive medical-grade PVC compliant with ISO 10993 standards. The material is formulated without harmful toxic plasticizers, offering exceptional softening properties at 37°C body temperature to minimize mucosal abrasion. Liquid silicone rubber (LSR) options and DEHP-free configurations are also available upon request.
HVLP Cuffed Tubes feature a thin-walled, high-volume low-pressure balloon that creates a reliable tracheal seal at low pressures (< 25 cm H2O), preventing mechanical ventilation air leaks and aspiration. Uncuffed Tubes are designed for non-ventilated patients, pediatric patients, or long-term tracheostomy management where secretion control is manageable. Fenestrated Tubes have small openings along the outer bend of the tube, allowing air to pass through the vocal cords to support patient speech and weaning protocols.
Our manufacturing complex operates under strict ISO 13485:2016 and ISO 9001 quality management standards. Our Tracheostomy Tube portfolio holds CE marking compliant with European medical device regulations. We supply complete technical documentation, including Free Sale Certificates (FSC), ISO 10993 biocompatibility summaries, stability test reports, biological indicator sterilization release logs, and Certificates of Analysis (CoA) with every export batch.
Yes, OEM and private-label programs represent a major segment of our global operations. We support custom buyer artwork, multi-language Instructions for Use (IFU), customized medical-grade paper-poly blister packaging, outer carton dimensions optimized for sea freight, and GS1-compliant UDI barcoding. Artwork proofing and sample approval are completed within 5-7 working days.
Single-use Tracheostomy Tubes are sterilized using Ethylene Oxide (EO) gas in validated 100% EO chambers according to ISO 11135 guidelines. Sterility Assurance Level (SAL) of 10⁻⁶ is verified using Bacillus atrophaeus biological indicators and chemical indicators. Products are packaged in peelable medical-grade paper/film pouches maintaining sterile integrity for 5 years from the date of manufacture.
For standard Mediplus brand catalog items, MOQ starts at 1,000 units per SKU size. Private-label OEM packaging orders begin at one 20-ft container mix across our product categories. Standard order lead times range from 3 to 4 weeks after artwork approval. Express shipments ship directly from Mundra Port or Nhava Sheva Port, India, under FOB, CIF, or CFR freight terms.
Our in-house Regulatory Affairs department provides complete dossier assistance for MoH registrations in Latin America, the Middle East, Africa, CIS, and Southeast Asia. We supply legalized/apostilled Certificates of Pharmaceutical Product (COPP) or Free Sale Certificates, Plant Inspection Certificates, Product Technical Files, and Risk Management Summaries (ISO 14971).
You can request technical specifications, product catalogs, and sample kits directly by clicking the Get Catalog button on this page to initiate a direct dialogue with our export sales engineering team, or email us at [email protected] with your target SKU matrix and estimated annual purchasing volume.
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