C-RAD Positioning AB
SE-MF-000022326 · Sweden · Uppsala
C-RAD Positioning AB is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 18 |
|---|---|
| Class IIb | 10 |
Most frequent device types declared: Catalyst+, HITSD Red, cAccessory.
Among these devices, 11 are declared active.
Devices declared under this manufacturer
- Catalyst+
- Catalyst+ HD
- Catalyst+ HD Ring Gantry
- HIT1 Green
- HIT1 Red
- HIT3
- HIT3 Green
- HIT3 Red
- HIT5
- HIT6
- HITSD Green
- HITSD MRI Red
Showing 12 of 28 declared devices.
Catalogue references include SP-004, SP003-0001, SP003-0002, SP005-0002, SP005-0005, SP006-0012.
European nomenclature codes declared: Z119010, Z119099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | C-RAD POSITIONING AB (SE) · FDA 3006621300 |
| Devices in EUDAMED | 28 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 28 |
|---|---|
| Found in the U.S. device database | 10 |
| Share | 35.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | C-RAD POSITIONING AB |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 2 |
| First licensed | 2014-04-30 |
Licence types: System (2).
Licensed under: SENTINEL, SP-001, CATALYST+.
North American profile: Both markets. C-RAD Positioning AB is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 002633 0007 | issued | 2028-11-13 |