Products for people with special needs are categorized as Medical Products and have to be CE certified.
The products we offer are for children, teenagers, and adults with special needs. Products for this group of people are categorized as Medical Products class I and have to comply with the EU Medical Device Regulation 2017/745 as of the 26th of May 2021.
It is at all times the manufacturer of the products who have to make sure that the Medical Products does comply with the MDR regulation.
The product range “Special Tomato” which we offer in the EU is manufactured outside of the EU. For this product range we, Global Carehab, are the authorized CE representative registered with an SRN number in the European database Eudamed for medical products.
