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CE mark application Zolidd®

Reference number
Coordinator Addbio AB
Funding from Vinnova SEK 181 909
Project duration December 2018 - June 2019
Status Completed
Venture Medtech4Health: Competence Enhancement in SME
Call Medtech4Health: competence enhancement for smaller companies

Purpose and goal

The aim of the project was to prepare AddBIOs first Product, Zolidd Dental, for CE-marking under MDR. We have now made the changes required to be able to make an application under the new regulation.

Expected results and effects

We have started tha application process with our NB. We assume that they will start the work in Q4 2019/Q1 2020, and we will be able to continue the wotk to expand the AddBIO portfolio. The CE-mark will enable us to release the product to the european market, and the knowledge is now in-house and will facilitate future applications.

Planned approach and implementation

The project has been conducted according to the plan, including regulalry meetings and communications with our consultant that we hired with help of the fundings recieved from Vinnova. We have recieved the support needed to feel secure to handle this work in-house in the future.

The project description has been provided by the project members themselves and the text has not been looked at by our editors.

Last updated 26 November 2018

Reference number 2018-04568

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