Statistics for Osstell AB

142Total Devices

7Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

2Countries

Certificate health for Osstell AB

No certificates registered for this manufacturer.

No devices registered for this manufacturer.

Devices placed in 2 countries

EUDAMED update: Dec 4, 2025

SE-MF-000002162

Active

JOHANSSON Henrik
Responsible for ensuring that the technical documentation and declaration of conformity are drawn up and kept up to date, and that the Post-Market Surveillance obligations are complied with in accordance with Article 10(10).
Hidden
OHLSON Toyah
Responsible for ensuring that the conformity of the devices is adequately controlled before they are released, in accordance with the quality management system under which the devices are manufactured.
Hidden
BRING Johan
Responsible for ensuring that the quality management system is suitable to cover at least the requirements of Regulation (EU) 2017/745 and ensuring that the Vigilance reporting obligations referred to in Articles 87 to 91 are fulfilled.
Hidden