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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 Ltd (trading as SelfiMed UK) 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 products sold by SelfiMed UK 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 before dispatch. This applies particularly to:

CPAP and BiPAP machines  •  Oxygen concentrators  •  Nebuliser systems  •  Patient ventilators  •  Certain infusion and dialysis equipment

Prescription Verification

SelfiMed UK reserves the right to request prescription documentation before processing an order. If documentation is requested, your order will be held until verification is complete. We will contact you promptly by email or phone.

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

Devices, Components & Accessories

Replacement parts, assembly responsibility and purchase conditions

Available Components

We supply individual components and accessories across all equipment categories — including CPAP mask parts, monitor cables, ECG electrodes, hoist slings, mattress covers and replacement parts for clinical equipment. These are provided as replacement or accessory items only and not as complete therapeutic systems unless listed as such.

Bundles, Kits & Assembly

Any bundles or kits are shipped unassembled unless otherwise stated and are not marketed as a configured medical device. Final assembly, calibration and correct application are the responsibility of the end user or qualified technician.

Purchase Confirmation

By purchasing, you confirm that you either have an existing prescription if required, or are purchasing for lawful replacement, training, institutional, 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. All products must be maintained, cleaned, and operated in strict accordance with the manufacturer's instructions for use (IFU).

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 by a director of Elarix Medical Ltd.

Important Safety Warning

Warning: Do not use pre-owned or refurbished equipment for emergency or critical care without professional medical oversight and appropriate commissioning. Always seek advice from a qualified healthcare professional before commencing any therapy with medical equipment.

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, diagnostics, or clinical recommendations. Any product information we provide is for informational and procurement purposes only.

Who to Consult

For questions regarding suitability or clinical use of any product, please consult your General Practitioner (GP), a licensed physician, nurse or specialist, or a qualified clinical or biomedical engineer. For equipment commissioning or service queries, contact the manufacturer directly or a qualified medical device technician.

Contact & Compliance Assistance

Get in touch for compliance, prescription or regulatory queries

Contact Details

For queries about compliance, prescriptions, or safe use of any product:

Email: info@selfimed.com
Compliance: support@elarixmedical.co.uk
Phone / WhatsApp: +44 7802 644820
Website: www.selfimed.com

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