Medical Device Policy
Elarix Medical Ltd · Company No. 16602969 · Regulated by the Medicines and Healthcare products Regulatory Agency (MHRA)
Regulatory Disclaimer
Our responsibilities and yours when purchasing medical equipment
Our Position
Elarix Medical supplies medical equipment and accessories on the clear understanding that:
We are not a healthcare provider and do not offer medical advice, diagnosis, or treatment. 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. Product classifications may differ outside the UK; buyers should consult their own national regulations if purchasing internationally.
Prescription-Only Devices
Products that may require a valid prescription before purchase
Which Products Require a Prescription?
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 CPAP machines, BiPAP machines, oxygen concentrators and nebuliser systems.
Prescription Verification
Elarix Medical Ltd reserves the right to request prescription documentation before processing an order. If documentation is requested, your order will be held until verification is complete.
CPAP Masks, Components & Accessories
Replacement parts, assembly responsibility and purchase conditions
Available Components
We supply individual CPAP/BiPAP mask components and accessories including frames, cushions, headgear, filters and tubing. These are provided as replacement parts only and not as complete therapeutic systems.
Bundles, Kits & Assembly
Any bundles or kits are shipped unassembled and are not marketed as a configured medical device. Final assembly and correct application are the responsibility of the end user.
Purchase Confirmation
By purchasing, you confirm that you either have an existing prescription if required, or are purchasing for lawful replacement, training, or accessory use.
Safety & Liability
Proper use, maintenance and liability limitations
Proper Use & Maintenance
Improper use, incorrect assembly, or failure to follow manufacturer instructions may result in injury or harm. Products must always be maintained, cleaned, and operated as directed by the manufacturer.
Liability Limitations
Elarix Medical Ltd accepts no liability for misuse, mishandling, or unauthorised modification of any product. All products are sold "as supplied", without any guarantee for a specific clinical outcome unless explicitly confirmed in writing.
Important Safety Warning
No Medical Advice
We are not licensed clinicians and cannot provide therapeutic guidance
Our Limitations
Staff at Elarix Medical Ltd are not licensed clinicians and cannot provide medical or therapeutic guidance.
Who to Consult
For questions regarding suitability or use of any product, please consult your General Practitioner (GP), a licensed physician or nurse, or a qualified clinical or biomedical engineer.
Contact & Compliance Assistance
Get in touch for compliance, prescription or safe use queries
Contact Details
For queries about compliance, prescriptions, or safe use, please contact us:
Email: support@elarixmedical.co.uk
Website: www.cpapsupply.co.uk
Legal Notice
Binding terms and warranty limitations
Binding Terms
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.
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Need Compliance Assistance?
Our team can help with prescription queries, regulatory questions and safe use of medical devices.