Certificates

Our medical devices meet stringent regulatory standards, certified under ISO 13485 and MDSAP.
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Medistim is certified according to ISO 13485 (PDF here) and MDSAP (PDF here)

All of our products are CE marked.

Please note that the validities of the certificates have been extended beyond the validity dates on the certificates under Regulation EU 2023/607.

The new dates are as follows:

Medistim MiraQ Systems – 31 December 2028

Download the confirmation letter on the extension of the certificates from the EU notified body here: Confirmation Letter

Certificate No.

Product

Download

C642091 Rev 0.0

Medistim MiraQ Systems

10000322610-PA-NA-NOR Rev 2.0

Medistim L15 Ultrasound Imaging probe

242086-2017-CE-NOR-NA-PS Rev 4.0

Medistim QuickFit TTFM probes (PS Probes)

10000322554-PA-NA-NOR Rev 2.0

Medistim Vascular TTFM probes (PV Probes)

10000322573-PA-NA-NOR Rev 2.0

Medistim Doppler probe