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COMPLIANCE

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.

Tip: Have your prescription or referral letter ready when ordering prescription-only devices. This helps us process your order without delay.

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

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

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

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Need Compliance Assistance?

Our team can help with prescription queries, regulatory questions and safe use of medical devices.

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