CathVision ApS
DK-MF-000008517 · Denmark · Copenhagen
CathVision ApS is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 4 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: CVHW-0015 R2.0, CVT-0069 R2.0.
Among these devices, 1 are declared active, 1 with a measuring function.
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 register | Registered with FDA |
|---|---|
| Matched entry | CATHVISION APS (DK) · FDA 3017401510 |
| Devices in EUDAMED | 5 |
| Country of registration | Denmark |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
20M00035CRT02 | amended | 2030-02-18 |