Now, keeping your hair during chemo is up to you.
AEMPS certification capillary cooling cap marks a milestone for Criobella® by allowing its cap to be marketed as a medical device in Spain. After a long and demanding process, Criobella® has obtained official authorisation from the Spanish Agency for Medicines and Health Products (AEMPS), allowing its capillary cooling cap to be marketed as a medical device. Class I medical device.
This certification certifies that the device complies with the requirements of safety, quality and traceability This is particularly important when it comes to products used during chemotherapy treatments.
This AEMPS certification capillary cooling cap guarantees compliance with the requirements of Spanish health regulations.
The impact of this authorisation has been reported in the national media, which reinforces the importance of the achievement:
Europa Press
El Confidencial Digital
Emprendedores Magazine
What the AEMPS certification guarantees:
✅ Assessment by the Spanish health authority
✅ Compliance with Regulation (EU) 2017/745
✅ Regulated use in clinical settings
✅ Increased confidence for patients and professionals
Thanks to the AEMPS certification capillary cooling cap, Criobella® reinforces its commitment to safety and clinical evidence.
The AEMPS certification makes Criobella's cap a regulated medical device, This is essential for both patients and healthcare professionals. Unlike solutions without official validation, this device has been evaluated according to technical, clinical and regulatory criteria.
From the patient's point of view, the difference is clear: using a certified cap is equivalent to using a product that has passed safety checks, instructions for use and post-marketing surveillance. It is similar to the difference between an authorised and an unregistered medicine.
For oncologists and hospital centres, certification means:
Possibility of recommend an approved device
Reducing legal uncertainty
Use of clear and documented protocols
Integration into the usual clinical setting
This breakthrough has been highlighted by various economic and health media, underlining both its medical and business impact:
El Confidencial Digital
https://www.elconfidencialdigital.com/articulo/an/criobella-logra-certificacion-aemps-gorro-enfriamiento-capilar/20250929123709981819.html
Emprendedores Magazine
https://emprendedores.es/noticias-de-empresa/criobella-logra-la-certificacion-de-la-aemps-para-su-gorro-de-enfriamiento-capilar/
These links not only provide SEO authority, but also real credibility with patients and professionals.
The AEMPS certification capillary cooling cap consolidates Criobella® as one of the few companies in Spain to offer a capillary cooling device with official regulatory backing. This recognition facilitates its use in hospitals, clinics and pharmacies, and brings peace of mind to both patients and oncologists.
Beyond authorisation, this step opens up new opportunities to improve information, education and access to solutions to help mitigate one of the most visible side effects of chemotherapy.
What does it mean to be a Class I medical device?
That it complies with the safety and control criteria established by European regulations.
Does certification guarantee full hair preservation?
No. Efficacy depends on the type of chemotherapy and the protocol applied.
Can an oncologist recommend it?
Yes, it is precisely the certification that facilitates their clinical recommendation.
Select the length of your chemotherapy sessions to get your personalised cold cap recommendation, along with the price and details of the ideal plan for you.
