Enzymatica’s common cold spray ColdZyme® has been re-certified under the Council Directive 93/42/EEC. ColdZyme® is branded PreCold® in Iceland.
(MDD) by the notified body Eurofins Product Testing. Thereby, ColdZyme will have a CE marking of the highest class, which implies that the product can be sold as a class III medical device within the EU until May 2024. ColdZyme and its documentation have been reviewed by Eurofins, which is an organization designated by a Competent authority for certification of medical devices within the EU. Eurofins has reviewed the complete documentation for ColdZyme including data for safety, efficacy and product benefits.
The re-certification process has covered a re-classification of ColdZyme from class I to class III. The background to the re-classification is a change of the interpretation of animal tissue, which is based on the fact that ColdZyme contains an enzyme (trypsin) derived from the atlantic cod (Gadus morhua). In this process, the intended use and product benefits have been reviewed and approved with respect to clinical efficacy and safety documentation. According to the re-certification by Eurofins the intended use is: ‘to treat and alleviate common cold’, and with the following product benefits:
- ColdZyme protects against common cold viruses.
- ColdZyme can help shorten the duration of a common cold if used at an early stage of the infection.
- ColdZyme alleviates common cold symptoms and soothes sore throat.
“This is a very gratifying notification. Eurofins has performed an extensive review of both Enzymatica’s processes and the documentation for ColdZyme, and found that the product meets the requirements for a CE marking class III. Thus, pre-clinical data, clinical data, production processes and quality system have been reviewed and found to correspond with the requirements of the highest classification for medical device products within the EU, which is a clear quality stamp and increases the trust for our common cold spray on an international level,” says Fredrik Lindberg, CEO of Enzymatica.
For more information, please contact:
Fredrik Lindberg, CEO Enzymatica AB
Phone: +46 (0)708-86 53 70 | Email: firstname.lastname@example.org
Carl-Johan Wachtmeister, Communication manager Enzymatica AB
Phone: +46 (0)701-88 50 21 | Email: email@example.com