Incipio Devices SA
CH-MF-000030518 · Switzerland · St. Blaise
Incipio Devices SA is registered in the European database on medical devices as a manufacturer, with 240 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 240 |
|---|
Most frequent device types declared: 50340100, 50740101, Straight Reamer Handle.
Among these devices, 1 are declared sterile, 192 reusable.
Authorised representative in the Union: MDSS GmbH.
Devices declared under this manufacturer
- 55° Angled reamer handle - large AO - Tri coupling
- ACE Acetabular Reamer ø40mm
- ACE Acetabular Reamer ø64mm
- Offset Cup Impactor - nose
- Offset reamer handle - Body
- Offset reamer handle - Hudson - Tri coupling (NC)
- Offset reamer handle - Stryker Z/H - Tri coupling (NL)
- Offset reamer handle - Stryker Z/H motor shaft
- Offset reamer handle - Tri coupling transmission (NL)
- Positioning Handle - M10x1.5 interface
- Positioning Handle - M8x1 interface
- Straight Reamer Handle - Large AO - Dual Coupling
Showing 12 of 240 declared devices.
Catalogue references include 131-171/02, 50141064, 50242511, 50244507, 50244521, 50244554.
European nomenclature codes declared: L0999, L091199, L99, L0922, L091102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Incipio Devices SA (CH) · FDA 3013223655 |
| Devices in EUDAMED | 240 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 240 |
|---|---|
| Found in the U.S. device database | 192 |
| Share | 80.0 % |
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. Incipio Devices SA is registered in the United States but was not found in the Canadian register.