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.
Devices declared under this manufacturer
- Blood Pressure Cable
- ECG Trunk Cable
- ECGenius System
- IECG Pin Box
- Stimulator Cable
Catalogue references include CVHW-0015 R2.0 Blood Pressure Cable, CVHW-0016 R1.0 Stimulator Cable, CVHW-0072 R2.0 ECG Trunk Cable, CVHW-0073 R3.0 IECG Pin Box, CVT-0069 R3.2 ECGenius System.
European nomenclature codes declared: C020180, C020199.
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 |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| 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. CathVision ApS is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
20M00035CRT02 | amended | 2030-02-18 |