Bonebridge AG
CH-MF-000013933 · Switzerland · Zug
Bonebridge AG is registered in the European database on medical devices as a manufacturer, with 308 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 248 |
|---|---|
| Class IIa | 60 |
Most frequent device types declared: BRUSIO Trauma Toolbox Plate, Bonebridge Instrument-IIa, Bonebridge Instrument-Im, Bonebridge Instrument-Ir, Bonebridge Screw.
Among these devices, 123 are declared sterile, 248 implantable, 60 reusable, 4 with a measuring function.
Authorised representative in the Union: Axxos GmbH.
Devices declared under this manufacturer
- Cortical Screw ø3.5mm L50mm
- Cortical Screw ø3.5mm L95mm
- Depth Gauge 2.5mm L8 - L60
- LORRAINE 3.5mm Extraarticular Distal Humerus Plate, 10 Hole, Right
- LORRAINE 3.5mm Medial Distal Humerus Plate, 4 Hole
- LORRAINE 3.5mm Posterolateral Distal Humerus Plate, 5 Hole, Right
- POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, Left
- POYA 3.5mm Medial Proximal Tibia Plate, 4 Hole, Left
- SALGINA 2.5mm Volar Distal Radius Plate, Standard, 12 Hole, Long, Left
- SALGINA 2.5mm Volar Distal Radius Plate, Standard, 5 Hole, Left
- SALTI Anterolateral Template
- Variable Angle Locking Screw Ø2.5mm L48mm
Showing 12 of 308 declared devices.
Catalogue references include B-111210, B-111230, B-160000, B-261000, B-314046, B-324050.
European nomenclature codes declared: P09120699, P09120599, L091001.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BONEBRIDGE AG (CH) · FDA 3021010222 |
| Devices in EUDAMED | 308 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 308 |
|---|---|
| Found in the U.S. device database | 293 |
| Share | 95.1 % |
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. Bonebridge AG is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 2477191 1 | supplemented | 2029-02-28 |