Medistim ASA
NO-MF-000002741 · Norway · Oslo
Medistim ASA is registered in the European database on medical devices as a manufacturer, with 88 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 46 |
|---|---|
| Class I | 42 |
Most frequent device types declared: PV100021, PV100031, PV100032, PV100052, PV100052-20.
Among these devices, 78 are declared active.
Devices declared under this manufacturer
- Medistim Doppler Probe
- Medistim L15 Imaging Ultrasound Probe
- Medistim MiraQ Cardiac System
- Medistim MiraQ Ultimate System
- Medistim MiraQ Vascular System
- Medistim Vascular TTFM Probe
- Medistim Vascular TTFM porbe
- Medistim Vascular TTFM probe
Showing 12 of 88 declared devices.
Catalogue references include MQC02011, MQC12021, MQV14012, MQV14021, PV100032, PV100052-20.
European nomenclature codes declared: Z11049099, Z11040299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDISTIM ASA (NO) · FDA 3003647374 |
| Devices in EUDAMED | 88 |
| Country of registration | Norway |
Device-level evidence
| Devices with a numeric GTIN | 88 |
|---|---|
| Found in the U.S. device database | 47 |
| Share | 53.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDISTIM ASA |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| Class 4 devices | 1 |
| First licensed | 2001-08-07 |
Licence types: Device Family (1), Device Group Family (1).
Licensed under: INTRA OPERATIVE ULTRASOUND PROBES, MEDISTIM MIRAQ SYSTEM.
North American profile: Both markets. Medistim ASA is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
C642091 | issued | 2029-10-14 |