ColdZyme® certified under the new EU medical device regulation (MDR)

"This is an important milestone in the history of Enzymatica as the MDR certification validates our scientific data and creates great commercial opportunities for us. In addition, it increases the consumer confidence in ColdZyme® as well as opens up new markets. The certification is highly anticipated by our partners since it ensures long term security which will contribute to Enzymatica's growth," says Claus Egstrand, CEO of Enzymatica. "This is an important milestone in the history of...

"This is an important milestone in the history of Enzymatica as the MDR certification validates our scientific data and creates great commercial opportunities for us. In addition, it increases the consumer confidence in ColdZyme® as well as opens up new markets. The certification is highly anticipated by our partners since it ensures long term security which will contribute to Enzymatica's growth," says Claus Egstrand, CEO of Enzymatica.

Eurofins has reviewed full data including safety, efficacy, and product claims. ColdZyme® has maintained the highest MDR classification, class III, during the process and both intended use and product claims are now able to expand due to the MDR-certification.

"This certification process has meant extensive review of our quality processes and product data in accordance with the medical device legislation. Our expanded, verified health claims will now help us to communicate ColdZyme's benefits and efficacy even more clearly towards customers, retailers, and partners," says Ann-Christine Provoost, Director Regulatory Affairs.

ColdZyme® MDR certification 

ColdZyme® provide an effective barrier that protects the oral cavity and throat and creates an osmotically active transient barrier that traps viruses deactivates and inhibits the viruses' ability to bond, deactivating their ability to infect cells. ColdZyme® products are now MDR certified with the following expanded intended use:             

and with the following expanded product claims:         

For more information, please visit https://coldzyme.co.uk/

About MDR

The Medical Device Regulation (MDR) is an EU regulation to ensure the safety and performance of medical devices.           

Read more 

For more information, please contact:

Claus Egstrand, CEO, Enzymatica AB
Phone: +44 7780 22 8385 | Email: claus.egstrand@enzymatica.com 

Stefan Olsson, Communication Manager, Enzymatica AB
Phone: +46 708 55 11 85 | Email: stefan.olsson@enzymatica.com

References:

1.  Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis. 2005
  Nov;5(11):718-25.

About Enzymatica
Enzymatica AB develops and sells products that treat and alleviate infections and symptoms in the upper respiratory tract. The products are based on the Penzyme® technology, which includes marine enzymes with unique properties. The best-selling product is ColdZyme®, a mouth spray for colds and cold-like symptoms of the upper respiratory tract.  ColdZyme has been launched in over 30 markets on four continents. The strategy is to continue to grow by developing more health products, strengthening the company's position in existing markets and expanding into new geographic markets through established partners.  The company is headquartered in Lund and is listed on Nasdaq First North Growth Market. Enzymatica's certified advisor is Carnegie Investment Bank AB (publ). For more information please visit www.enzymatica.com. 

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