Switzerland-based Regen Lab has received CE certification for three medical devices, namely REGENKIT, CELLULAR MATRIX fig and Arthrovisc.
REGENKIT is a preparation of platelet-rich plasma (PRP) while CELLULAR MATRIX fig is a combination of PRP and hyaluronic acid (HA). Arthrovisc comprises syringes filled with HA.
The PRP solutions received the certificates from the notified body BSI based on the evaluation of Regen Lab’s quality management system and technical documentation.
The validity period of these certificates spans five years, commencing on 25 April 2023 and concluding on 24 April 2028.
Regen Lab’s certifications strengthen its competitive position both in the PRP market and when combined with HA.
The CE certification obtained for the devices under Medical Device Regulation bolsters the company’s positioning in the field of autologous tissue engineering therapies.
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Regen Lab’s autologous tissue engineering solutions are based on PRP preparation from the patient’s own blood and combined therapy that includes PRP and HA.
The certification also highlights the company’s patented technologies, which are available in more than 90 countries.
These technologies were used to treat patients in musculoskeletal, dermo-esthetics, wound care and urogenital therapeutic areas.
The commercial-stage medical technology company is engaged in the development, registration, manufacturing and commercialisation of tissue engineering solutions.
Its products are produced at the group facilities in Le Mont sur Lausanne, Switzerland, and Brooklyn, New York, US.
The company will also start manufacturing operations in Les Ulis, Paris, France, in the third quarter of this year.