Direct factory export solutions for Irish healthcare providers, offering medical-grade silicone catheterization kits, tube securement devices, and oxygen therapy consumables.
Medical-grade hypoallergenic adhesive prevent pull-trauma and mechanical shear stress in long-term catheterization.
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100% translucent biocompatible silicone with integrated irrigation channel for post-operative bladder flushing.
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Factory price sterile urology catheters with symmetrical balloon expansion and smooth distal eyes.
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Comprehensive clinical insertion kit designed to lower Catheter-Associated Urinary Tract Infections (CAUTI).
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Kink-resistant lumen construction providing maximum flow rate efficiency during long-term catheterization.
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Color-coded inflation valves compliant with international sizing guidelines for swift clinical identification.
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Breathable non-woven fabric anchor pad designed for sensitive patient skin in geriatric and ICU settings.
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Ultra-soft atraumatic tip design engineered specifically for pediatric urology and neonatal ICU requirements.
Contact UsAn in-depth analysis of polymer selection, oxygen mask design, localized regulatory frameworks under HPRA, and optimized direct shipping routes into Dublin and Cork.
In modern respiratory clinical care across Ireland—spanning acute hospitals under the Health Service Executive (HSE) to community-based Sláintecare initiatives—the choice of polymer materials in single-use oxygen masks is paramount. Historical reliance on plasticized PVC containing di(2-ethylhexyl)phthalate (DEHP) presented significant endocrine-disrupting risks during prolonged oxygen delivery. As an ISO 13485-certified original equipment manufacturer (OEM), Angiplast utilizes next-generation non-phthalate medical-grade PVC and liquid silicone rubbers (LSR) engineered specifically to conform with strict European REACH and EU MDR 2017/745 Annex I General Safety and Performance Requirements (GSPR).
Our oxygen masks feature soft, ergonomic anatomical contours that achieve a seal pressure profile minimizing skin ischemia and facial pressure sores—a crucial metric monitored in Irish ICU and sub-acute care units. Key technical attributes of our material matrix include:
| Parameter | Standard Simple Oxygen Mask | Venturi Mask System | Non-Rebreather Mask (NRBM) |
|---|---|---|---|
| FiO2 Range Delivered | 35% – 50% at 5–8 L/min | 24%, 28%, 31%, 35%, 40%, 50% (Exact) | 60% – 90% at 10–15 L/min |
| Target Clinical Use | Mild to moderate hypoxia | COPD / Hypercapnic respiratory failure | Severe hypoxemia / Trauma resuscitation |
| Dead Space Volume | < 100 mL | Calibrated Dilution Port (Zero Dead Space) | Integrated 1000 mL Reservoir Bag |
| Valve Configuration | Exhalation Ports (Open) | Color-coded Venturi Diluters | One-Way Silicone Flapper Valves |
| EU MDR Classification | Class IIa (Rule 11) | Class IIa (Rule 11) | Class IIa (Rule 11) |
For chronic obstructive pulmonary disease (COPD) management—a high-prevalence condition within Ireland's aging demographic—uncontrolled oxygen delivery can abolish the hypoxic drive. Our precision Venturi mask kits utilize high-precision injection-molded diluter valves that leverage the Bernoulli Principle. By passing pure oxygen through a restricted orifice, a predictable static pressure drop is created, drawing in ambient air through calibrated entrainment ports to generate a precise Fraction of Inspired Oxygen (FiO2).
Each entrainment valve manufactured in our controlled cleanroom facility undergoes 100% automated optical sensor inspection. Dilution ratios are strictly controlled across flow rates from 2 to 15 L/min, giving Irish clinical staff absolute certainty in FiO2 titration. Furthermore, integrated humidification adapters allow seamless inline connection to sterile water bubblers, preventing upper airway mucosal desiccation during multi-day therapeutic regimens in hospital wards like those at St. James's Hospital, Dublin, or Cork University Hospital.
Hospital procurement managers and medical supply distributors in Ireland operate under distinct institutional environments. Angiplast tailor-engineers packaging, labeling, and product configurations to meet the specific clinical workflows across three primary Irish operational sectors:
High-volume supply of standardized sterile oxygen masks, nebulizer kits, and silicone Foley catheters configured for fast-paced Emergency Departments (EDs) and Intensive Care Units (ICUs). Packaged in peel-open medical pouches compatible with centralized aseptic storage systems.
Rugged, compact-packaged Non-Rebreather Masks and high-output nebulizers built to withstand physical transport dynamics in pre-hospital emergency medical service (EMS) vehicles across rural and urban Ireland.
Intuitive, soft-fit nasal oxygen cannulas and home-use Venturi kits optimized for patient self-administration, supporting Ireland's strategic shift toward decentralised, community-based respiratory management.
Navigating medical device procurement in Ireland post-Brexit requires absolute regulatory clarity. As Ireland's Health Products Regulatory Authority (HPRA) enforces strict adherence to EU MDR 2017/745, importing entities must ensure that technical documentation, clinical evaluations, and UDI (Unique Device Identification) barcoding are flawlessly executed.
Angiplast acts as a complete solution partner for Irish importers and distributors:
Angiplast Pvt. Ltd. combines over 30 years of ISO 13485-certified single-use medical device expertise with end-to-end OEM/CDMO capabilities.
Assembly, ultrasonic welding, and thermoforming pouch packaging occur inside monitored Class 10,000 (ISO Class 7) cleanroom facilities maintaining strict microbial bioburden controls.
Our dedicated Ethylene Oxide (ETO) sterilizer plant processes every batch in accordance with EN ISO 11135 validation, ensuring residual levels are well below EN ISO 10993-7 thresholds.
Full-scope contract manufacturing: custom mold design, proprietary valve engineering, personalized pouch artwork, and multilingual Instructions for Use (IFUs) tailored for Irish healthcare tenders.
Direct technical and logistical insights for medical equipment importers, tender officers, and clinical procurement teams in Ireland.
We supply complete EU MDR-compliant technical documentation, including ISO 13485 certificates, CE certificates issued under valid European conformity assessment routes, ISO 10993 biocompatibility testing data, and Free Sale Certificates (FSC). Our designated EU Authorized Representative (EC REP) guarantees swift filing capability with the HPRA and inclusion in the EUDAMED portal.
Yes. All oxygen mask ranges (simple, Venturi, non-rebreather) and silicone catheterization lines produced for European markets are manufactured from 100% DEHP-free, phthalate-free, and natural rubber latex-free materials. This minimizes allergic responses and complies with strict European clinical safety directives regarding endocrine-disrupting chemicals.
For standard catalogue items under private label or OEM configurations, typical MOQs start at one full production batch per SKU (usually 5,000 to 10,000 units depending on device complexity). Direct ocean container transit from Gujarat port facilities to Dublin Port or Port of Cork takes approximately 22–28 days, ensuring rapid stock replenishment for Irish distributors.
Absolutely. Our dedicated graphic design and regulatory team routinely produces customized medical pouch artwork, unit packaging, and outer cartons containing dual-language IFUs (English/Irish or multilingual European formats), GS1 barcodes, and specific tender contract numbers to ensure seamless acceptance by HSE procurement logistics centers.
Partner with a global medical device manufacturer trusted across 52+ countries. Get rapid pricing, regulatory technical files, and sample kits for your Irish healthcare procurement tenders.
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