ISO 13485 & CE MDR Certified Manufacturer

China Wholesale Guedel Airway Manufacturer & Exporters in the Ireland Market

Engineered for Clinical Precision: Supplying Irish HSE Hospitals, Private Health Networks, and Emergency Medical Suppliers with Premium Oropharyngeal Airway Devices.

Featured Product Range

Precision Airway Management & Medical Disposables

Explore our export-validated clinical devices designed for seamless emergency ventilation, airway maintenance, and critical care procedures across Ireland.

Super Quality Permanent HD Catheter Set Silicone Cuffed Tunneled Dialysis Catheter

Permanent Silicone Cuffed Tunneled HD Catheter Set

15F Long-term radiopaque silicone hemodialysis kit designed for vascular access integrity.

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Surgical Pack Included EO Sterile Class III Hemodialysis Catheter

EO Sterile Surgical Hemodialysis Catheter Pack

Class III clinical dialysis equipment kit with pre-attached connectors and atraumatic introducer.

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Permanent Tunneled Hemodialysis Catheter Long Term Straight Dialysis Catheter

Double Lumen Tunneled Straight HD Catheter

Biocompatible medical polymer construction ensuring smooth flow rates and minimum shear stress.

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CE MDR Certified Transparent Silicone Hemodialysis Catheter

CE MDR Certified TPU / Silicone Hemodialysis Lines

Single, double, and triple lumen options engineered for intensive dialysis and vascular access.

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Disposable Double Lumen Hemodialysis Catheter Kit

Disposable Double Lumen Hemodialysis Kit

Complete procedure kit equipped with guidewire, vessel dilator, and scalpel for acute insertion.

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Sterile Disposable Extracorporeal Circulation Hemodialysis Catheter Kit

Extracorporeal Circulation Dialysis Kit

Sterile single-use medical consumables tailored for hospital intensive care and nephrology units.

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Medical Supplies Hemodialysis Catheter Kit Double Lumen 7Fr

7Fr Clinical Double Lumen Hemodialysis Kit

Pediatric and adult sizing precision, meeting rigorous international ISO medical device standards.

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Wholesale Dialysis Catheters Medical Grade Central Venous Catheter

Medical Grade Monofil Central Venous Catheter

High-grade polymer construction with 2-year validated shelf life under EO sterilization protocols.

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36+
Years Manufacturing Excellence
70+
Global Export Destinations
ISO 13485
CE MDR Certified Facilities
100%
Single-Use EO Sterile Verification
Strategic Whitepaper Dossier

Navigating Airway Management Procurement in the Irish Healthcare Sector

An authoritative analysis of Ireland's Health Service Executive (HSE) compliance standards, hospital emergency supply chains, and bulk wholesale logistics.

The Irish healthcare ecosystem—comprising the public Health Service Executive (HSE) hospital networks, voluntary acute hospitals (such as Beaumont Hospital, St. James’s Hospital, and Cork University Hospital), and private clinical operators (like Beacon Hospital and Blackrock Clinic)—maintains some of the world's most stringent quality benchmarks for airway devices. In resuscitation, general anesthesia, and emergency medical services (EMS), the Guedel Oropharyngeal Airway remains an indispensable first-line medical disposable.

Post-Brexit structural shifts in European logistics have prompted Irish healthcare buyers, medical wholesalers, and tender agents to seek direct, resilient supply chains with primary manufacturers in China. By bypassing intermediate European brokerage layers, Irish distributors secure guaranteed stock availability, direct regulatory traceability, and significant unit-cost efficiency without compromising on EU MDR 2017/745 compliance.

"Information Gain Insight: Modern Irish clinical procurement mandates full ISO 5364:2016 color-coding compliance, phthalate-free/DEHP-free medical PVC composition, and reinforced bite-block structures to ensure patient safety across pre-hospital emergency care and ICU ventilation."

State of the art cleanroom medical device production facility
Engineering Standards

Guedel Oropharyngeal Airway: Material Science & Design Mechanics

Detailed technical specifications adhering strictly to international ISO 5364 and European Union medical device directives.

Dual-Channel Airway Path

Engineered with a central lumen and lateral suction channels, facilitating effortless catheter insertion and secretions clearance without occluding the primary airway.

Reinforced Color-Coded Bite Block

Features a color-coded rigid insert at the proximal end conforming to ISO 5364:2016 size recognition. Prevents airway collapse if the patient bites down during emergence from anesthesia.

Medical-Grade DEHP-Free PVC

Manufactured using semi-rigid, non-toxic, latex-free polymer compounds. Softened bevel edges minimize mucosal trauma during insertion into the pharyngeal wall.

ISO 5364 Standard Guedel Airway Sizing Matrix

ISO Size (mm) Color Code Patient Demographic Nominal Length (mm) Sterilization Method Packaging Type
Size 000 (40mm) Pink / Clear Neonate / Premature 40 mm Ethylene Oxide (EO) Individual Peel pouch / 500 Pcs Box
Size 00 (50mm) Blue Infant 50 mm Ethylene Oxide (EO) Individual Peel pouch / 500 Pcs Box
Size 0 (60mm) Black Child / Pediatric 60 mm Ethylene Oxide (EO) Individual Peel pouch / 500 Pcs Box
Size 1 (70mm) White Small Adult / Youth 70 mm Ethylene Oxide (EO) Individual Peel pouch / 500 Pcs Box
Size 2 (80mm) Green Medium Adult 80 mm Ethylene Oxide (EO) Individual Peel pouch / 500 Pcs Box
Size 3 (90mm) Yellow Large Adult 90 mm Ethylene Oxide (EO) Individual Peel pouch / 500 Pcs Box
Size 4 (100mm) Red Extra Large Adult 100 mm Ethylene Oxide (EO) Individual Peel pouch / 500 Pcs Box
Size 5 (110mm) Orange / Purple Bariatric Adult 110 mm Ethylene Oxide (EO) Individual Peel pouch / 500 Pcs Box
Clinical Integration

Localized Application Scenarios Across Ireland's Healthcare Ecosystem

Deploying sterile Guedel airways across acute care hospitals, emergency medical response teams, and specialized clinical settings throughout Ireland.

Pre-Hospital EMS & Ambulance Services

Utilized by the National Ambulance Service (NAS) and Dublin Fire Brigade (DFB) paramedics under Pre-Hospital Emergency Care Council (PHECC) clinical practice guidelines for rapid airway stabilization in unconscious patients.

Hospital Emergency Departments & Resuscitation Bays

Essential consumable in trauma suites across Dublin, Cork, Galway, and Limerick acute facilities for maintaining pharyngeal patency during spontaneous or bag-valve-mask (BVM) manual ventilation.

Operating Theatres & PACU (Post-Anesthesia Care Unit)

Deploys as a routine airway adjunct during emergence from general anesthesia to prevent soft tissue obstruction caused by tongue displacement against the posterior pharyngeal wall.

Industry Trends

Key Drivers Shaping Ireland's Airway Disposable Market

Understanding shifting regulatory compliance, environmental policies, and emergency preparedness in Irish medical procurement.

  • MDR (EU 2017/745) Mandate: Irish health authorities require full technical documentation, clinical evaluations, and Notified Body approval for all Class IIa/Class I sterile airway items.
  • Elimination of Phthalates (DEHP-Free): High demand for medical-grade PVC polymers free of harmful plasticizers, protecting vulnerable pediatric and neonatal intensive care patients.
  • Single-Use Protocol to Mitigate vCJD Risk: Ireland's strict infection control directives favor 100% single-use EO sterile Guedel airways over reusable rubber variants to eliminate cross-contamination hazards.
  • Supply Chain Localization & Direct B2B Wholesale: Wholesalers in Dublin and Shannon are securing direct factory contracts with Chinese manufacturing hubs to eliminate lead-time bottlenecks.

Our OEM manufacturing services empower Irish medical brand owners to offer custom packaging, barcoded UDI (Unique Device Identification), and multilingual Instructions for Use (IFU) tailored for HSE tender compliance.

Factory Expertise

Why Leading Global Suppliers Partner with Our Cleanroom Facility

Combining 36+ years of medical device engineering with modern automated production lines and stringent Quality Assurance dossiers.

ISO 13485 & CE MDR Accredited

Our state-of-the-art facility operates under strict ISO 13485 Quality Management Systems. Products hold full CE certification under the EU Medical Device Regulation (MDR).

ISO Class 7 & Class 8 Cleanrooms

Molding, extrusion, and secondary assembly occur in environmental cleanroom conditions equipped with automated continuous particle monitoring and laminar flow control.

EO Sterilization & Traceability

Every single batch undergoes validated Ethylene Oxide (EO) sterilization. Batch-specific Certificates of Analysis (CoA) and residual EO testing dossiers accompany all export containers.

Global Export Capability (70+ Countries)

Over three decades exporting single-use anesthesia, dialysis, urology, and respiratory disposables to European, American, Middle Eastern, and Asian hospital markets.

Turnkey OEM & Private Label Services

Full customization support including OEM mold creation, buyer-specified artwork proofing, inner box design, UDI labeling, and customized outer shipping cartons.

Competitive Landed Cost Efficiency

Direct factory wholesale pricing structure allows Irish distributors to achieve higher profit margins while submitting highly competitive bids in public HSE tenders.

Procurement Guidance

Irish Procurement & Compliance FAQ

Clear, direct answers to common regulatory, shipping, and quality assurance questions from Irish healthcare buyers and medical importers.

Do your Guedel airways meet European Union MDR (2017/745) requirements for sale in Ireland?
Yes. Our Guedel Oropharyngeal Airways are manufactured under strict ISO 13485 Quality Management Systems and hold full CE Certification under the EU MDR framework. We provide complete technical files, Declaration of Conformity (DoC), biocompatibility reports (ISO 10993), and sterilization validation dossiers required by Ireland's Health Products Regulatory Authority (HPRA) and HSE procurement committees.
What materials are used in manufacturing your Guedel airways, and are they latex/DEHP free?
Our Guedel airways are manufactured using 100% virgin, medical-grade semi-rigid PVC. They are entirely DEHP-free, phthalate-free, and 100% latex-free. This ensures complete patient safety against chemical toxicity and latex-induced anaphylaxis during emergency airway management.
Can you provide custom color-coding or private label OEM packaging for Irish medical brand owners?
Absolutely. We offer comprehensive OEM/Private Label services. Our artwork team can customize individual sterile peel pouches, inner display boxes, outer shipping cartons, GS1-compliant UDI barcodes, and English/Irish multilingual IFUs. Artwork proofs are typically finalized within 5–7 working days prior to production release.
What is the standard Minimum Order Quantity (MOQ) and lead time for wholesale exports to Ireland?
For standard catalog items with factory packaging, minimum order quantities start at 5,000 units per size (or mixed container loads). For custom private-label OEM orders, production runs start at one 20-ft container. Lead time is typically 3 to 4 weeks from artwork approval. Direct container shipments can be dispatched to Dublin Port or Cork Port on FOB, CIF, or CFR freight terms.
How is product sterility validated and guaranteed throughout international transit?
Each batch undergoes validated Ethylene Oxide (EO) sterilization adhering to ISO 11135 standards. Sterility is verified using chemical indicators, biological indicators (Bacillus atrophaeus), and EO residue limit testing. Individual devices are sealed in medical-grade paper-poly peel pouches that maintain sterile barrier integrity for up to 5 years under standard store conditions.
How can an Irish distributor or healthcare procurement manager request product samples and pricing?
You can request pricing dossiers, technical specification sheets, and physical sample kits by clicking the catalog button on this page. Our dedicated export desk will respond within 24 hours with complete price matrices, shipping estimates, and documentation packs tailored for your market needs.

Partner with China's Premier Guedel Airway Manufacturer

Equip your distribution network with high-precision, CE MDR certified airway management devices. Get direct factory pricing, technical dossiers, and sample packs delivered to Ireland.