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 IIa | 7 |
|---|
Among these devices, 7 are declared active.
Devices declared under this manufacturer
- BoneMRI
Catalogue references include v1.10, v1.11, v1.12, v1.6, v1.7, v1.8.
European nomenclature codes declared: V92.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MRIGUIDANCE B.V. (NL) · FDA 3027986210 |
| Devices in EUDAMED | 7 |
| Country of registration | Netherlands |
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. MRIguidance B.V. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
23M00065CRT01 | supplemented | 2028-12-02 |