RAYSEARCH LABORATORIES AB (PUBL)
SE-MF-000001908 · Sweden · Stockholm
RAYSEARCH LABORATORIES AB (PUBL) is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 14 |
|---|
Among these devices, 14 are declared active.
Devices declared under this manufacturer
- RayCare v2025
- RayCare v2025 SP-Probeat
- RayCare v2025 SP1
- RayCare v2025 SP4
- RayCare v2025 SP5
- RayCare v2026
- RayStation 2023B
- RayStation RayCommand v2025 SPC1
- RayStation RayCommand v2025 SPC2
- RayStation v2025
- RayStation v2025 SP1
- RayStation v2025 SP1B
Showing 12 of 14 declared devices.
Catalogue references include 10.0, 14.0, 17.0, 17.1, 9.1, 9.2.
European nomenclature codes declared: Z11019082.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | RaySearch Laboratories AB (publ) (SE) · FDA 3007774465 |
| Devices in EUDAMED | 14 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 7.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | RAYSEARCH LABORATORIES AB (PUBL) |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2010-07-28 |
Licence types: Device Family (1).
Licensed under: RAYSTATION.
North American profile: Both markets. RAYSEARCH LABORATORIES AB (PUBL) is registered in both the United States and Canada.