FOI release

Conformity assessment & Supporting documentation for ConvaNiox

Some or all of the information requested was not provided because we didn't hold it.

Case reference FOI2025/01218

Received 20 November 2025

Published 31 December 2025

Request

We would like to formally request the following information regarding the medical device ConvaNiox: • Conformity assessment conducted by UK Approved Bodies, followed by registration with the MHRA. • Supporting documentation submitted as part of the application for CE marking.

Response

See attached

Documents

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