Blue Ortho SAS
FR-MF-000002436 · France · Meylan
Blue Ortho SAS is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 31 |
|---|
Among these devices, 2 are declared sterile, 31 active, 28 with a measuring function.
Devices declared under this manufacturer
- GPS Ankle - Case Manager
- GPS Ankle - Navigation
- GPS Knee - TKA Pro
- GPS Mobile cart
- GPS Probe Tracker P
- GPS Station Lower mounting arm
- GPS Station Mounting arm clamp
- GPS Station v2 Carrying case
- GPS Station v3 - Carrying Case
- GPS Tracker F
- GPS Tracker G
- Shoulder Planning App
Showing 12 of 31 declared devices.
Catalogue references include A00206, A10006, I00032, J00011, J00120, L00002.
European nomenclature codes declared: Z12011480, Z12011482, Z12011485.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BLUE ORTHO (FR) · FDA 3008027912 |
| Devices in EUDAMED | 31 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 31 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 3.2 % |
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. Blue Ortho SAS is registered in the United States but was not found in the Canadian register.