certifications

iso 13485:2016 & EN ISO 13485:2016

Fluisense operates a Quality Management System which complies with the requirements of ISO 13485:2016 and EN ISO 13485:2016.

Certificate number: MD 674969

Download the certificate here: Certificate of registration

Fluisense has a certified Class 8 clean-room for contract ma nufacturing of sterile medical devices.

Fluisense has initiated the healthy volunteer study at DanTrials.

Fluisense has been granted patent in the US.

COmpany info

Fluisense ApS

CVR/VAT: DK32780571

Office hours: Mon - Fri 8 am - 4 pm CET

ADdress

Gydevang 20A

DK-3450 Allerød

Denmark

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