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MRIguidance B.V.

NL-MF-000002682 · Netherlands · Utrecht

MRIguidance B.V. is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa7

Among these devices, 7 are declared active.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMRIGUIDANCE B.V. (NL) · FDA 3027986210
Devices in EUDAMED7
Country of registrationNetherlands

Notified body certificates

CertificateStatusExpiry
23M00065CRT01supplemented2028-12-02

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