Xstrahl Limited
GB-MF-000031943 · United Kingdom · Walsall
Xstrahl Limited is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 9 |
|---|
Most frequent device types declared: Xstrahl 100 Therapeutic X-Ray System, Xstrahl 150 Therapeutic X-Ray System - Ceiling, Xstrahl 150 Therapeutic X-Ray System - Floor, Xstrahl 200 Therapeutic X-Ray System - Floor, Xstrahl 200 X-Ray System - Ceiling.
Among these devices, 9 are declared active.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- Xstrahl 100 Therapeutic X-Ray System
- Xstrahl 150 Therapeutic X-Ray System
- Xstrahl 200 Therapeutic X-Ray System
- Xstrahl 300 Therapeutic X-Ray System
- Xstrahl 80 Therapeutic X-Ray System (RADiant)
- Xstrahl XBeam Standalone Software v1.5.5
Catalogue references include X100, X150C, X150F, X200C, X200F, X300C.
European nomenclature codes declared: Z11019099, Z11019082.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | XSTRAHL LIMITED (GB) · FDA 3004561814 |
| Devices in EUDAMED | 9 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 8 |
| Share | 88.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | XSTRAHL LIMITED |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2004-04-05 |
Licence types: Device Family (1).
Licensed under: XSTRAHL SERIES X-RAY THERAPY UNITS.
North American profile: Both markets. Xstrahl Limited is registered in both the United States and Canada.