Medical Device Policy – Elarix Medical Ltd
With our Medical Device Policy, at Elarix Medical Ltd, we are committed to upholding strict regulatory and safety standards. All products are supplied in accordance with UK requirements for medical devices as regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) and other applicable legislation.
Regulatory Disclaimer
Elarix Medical supplies medical equipment and accessories on the clear understanding that:
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We are not a healthcare provider and do not offer medical advice, diagnosis, or treatment.
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Customers are responsible for ensuring they are authorised to purchase and use the equipment in line with UK law or the laws of their local jurisdiction.
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Product classifications may differ outside the UK; buyers should consult their own national regulations if purchasing internationally.
Prescription-Only Devices
Certain respiratory and therapeutic products fall under the category of prescription-only medical devices in the UK. Orders for these products may require verification of a valid prescription or clinical directive. This applies particularly to:
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CPAP (Continuous Positive Airway Pressure) devices
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BiPAP (BiLevel Positive Airway Pressure) devices
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Oxygen concentrators
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Nebuliser systems
Elarix Medical Ltd reserves the right to request prescription documentation before processing an order.
CPAP Masks, Components & Accessories
We also supply individual CPAP/BiPAP mask components and accessories, such as:
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Frames
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Cushions
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Headgear
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Filters and tubing
These are provided as replacement parts only and not as complete therapeutic systems.
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Any bundles or kits are shipped unassembled and are not marketed as a configured medical device.
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Final assembly and correct application are the responsibility of the end user.
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By purchasing, you confirm that you either:
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Have an existing prescription if required, or
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Are purchasing for lawful replacement, training, or accessory use.
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Safety & Liability
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Improper use, incorrect assembly, or failure to follow manufacturer instructions may result in injury or harm.
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Products must always be maintained, cleaned, and operated as directed by the manufacturer.
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Elarix Medical Ltd accepts no liability for misuse, mishandling, or unauthorised modification of any product.
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All products are sold “as supplied”, without any guarantee for a specific clinical outcome unless explicitly confirmed in writing.
⚠️ Warning: Do not use used or refurbished equipment for emergency or critical care without professional medical oversight. Always seek advice from a qualified healthcare professional before commencing CPAP or related therapies.
No Medical Advice
Staff at Elarix Medical Ltd are not licensed clinicians and cannot provide medical or therapeutic guidance. For questions regarding suitability or use, please consult:
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Your General Practitioner (GP)
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A licensed physician or nurse
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A qualified clinical or biomedical engineer
Contact & Compliance Assistance
For queries about compliance, prescriptions, or safe use, please contact:
📧 support@elarixmedical.co.uk
🌐 www.cpapsupply.co.uk
Legal Notice
All equipment supplied by Elarix Medical Ltd is offered in good faith but without any warranty of suitability for specific therapeutic purposes, unless expressly stated. By purchasing from us, you agree to comply with all regulatory requirements and assume full responsibility for the lawful, safe, and appropriate use of any item supplied.