Medical Device Disclaimer

At CPAP Studio, we take compliance seriously and follow all UK medical device requirements as regulated by the Medicines and Healthcare products Regulatory Agency (MHRA), along with all relevant health and safety standards.

Medical Device Disclaimer

At CPAPStudio, we take regulatory compliance seriously and follow the requirements set by the Medicines and Healthcare products Regulatory Agency (MHRA) and relevant UK safety standards.

Prescription-Only Devices

UK regulations classify some respiratory equipment as prescription-only medical devices. For these items, we may need to confirm a valid prescription before processing your order. This applies in particular to:
  • CPAP (Continuous Positive Airway Pressure) devices
  • BiPAP (BiLevel Positive Airway Pressure) devices
  • Oxygen concentrators
  • Nebuliser systems

CPAP Masks, Parts & Accessories

We also offer CPAP/BiPAP mask components and accessories (e.g., frames, cushions, headgear, filters, tubing). These are supplied as separate, replacement components only, not as a complete therapeutic system. Any final assembly is the responsibility of the end user.

While a fully assembled mask with headgear may be classified as a complete “patient interface” (and therefore require a prescription), we supply all mask-related items as separate, non-configured replacement components.

All bundled kits are shipped unassembled and are not sold or marketed as a therapeutic system. Final assembly is the responsibility of the end user.

By purchasing accessories, you acknowledge that you:

  • Already have an existing prescription or clinical directive (if required); or

  • Are purchasing for lawful replacement, educational, or accessory use; and

  • Understand the correct application of CPAP-related equipment.

Need Assistance?

For help submitting a prescription or determining if one is required, please contact our team:

Email: info@cpapstudio.co.uk

Liability Disclaimer

  • CPAPStudio provides no medical advice, diagnosis, or treatment.

  • We accept no liability for misuse, mishandling, or failure to maintain any product sold.

  • We are not responsible for injury, death, or property damage resulting from improper use.

  • All products are sold “as-is” without guarantees for specific clinical applications unless explicitly stated in writing.

  • By completing a purchase, you accept full responsibility for the evaluation, safe handling, and lawful use of all items.

Safety Warning ⚠

Medical devices can pose serious risks if not correctly maintained, assembled, or used. Improper use may result in injury, clinical harm, or death.

  • Do not purchase used or refurbished devices for emergency care or for critically ill patients without the direction of a medical professional.

  • Always follow manufacturer instructions, and consult a healthcare provider before using CPAP or related respiratory equipment.

Regulatory Compliance

  • Buyers are responsible for ensuring they are authorised to purchase and use medical devices under their local law.

  • Product classification may vary by country, and customers should consult local regulatory guidelines if outside the UK.

No Medical Advice Provided

CPAPStudio staff are not qualified to provide medical advice or clinical training. For advice on suitability or usage, consult:

  • Your GP (General Practitioner)

  • A registered physician or nurse

  • A qualified biomedical or clinical engineer

Contact Us

For queries or compliance assistance, please contact:
📧 info@cpapstudio.co.uk
🌐 www.cpapstudio.co.uk

Legal Notice

Regardless of origin, labelling, or documentation, all equipment sold by CPAPStudio is offered as-is and is not certified for any specific therapeutic use unless explicitly stated.

By purchasing from CPAPStudio, you acknowledge and agree to all terms of this disclaimer and assume full responsibility for safe and lawful use.