Boule Medical AB
SE-MF-000001911 · Sweden · Spånga
Boule Medical AB is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- Medonic M-serie Diluent 20L
- Medonic M-serie DualPack, RFID
- Medonic M-series Dual-pack
- Medonic M-series Lyse, 5L
- Medonic M-series Lyse, RFID
- Medonic M-series M32 B
- Medonic M-series M32 C AR
- Medonic M-series M32 S BD AR
- Swelab Alfa ComboPack 200
- Swelab Alfa Plus Cap AR
- Swelab Alfa Plus Standard
- Swelab AlfaDiluent, 900 cycles
Showing 12 of 21 declared devices.
Catalogue references include 1420021, 1420026, 1504123, 1504124, 1504125, 1504127.
European nomenclature codes declared: W0103010105, W0202010201, W0501010203.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BOULE MEDICAL AB (SE) · FDA 3004008703 |
| Devices in EUDAMED | 21 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 21 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 4.8 % |
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. Boule Medical AB is registered in the United States but was not found in the Canadian register.