Institut Straumann AG
CH-MF-000009933 · Switzerland · Basel
Institut Straumann AG is registered in the European database on medical devices as a manufacturer, with 2 449 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 1 615 |
|---|---|
| Class IIa | 834 |
Among these devices, 1 039 are declared sterile, 1 615 implantable, 2 active.
Authorised representative in the Union: Etkon GmbH.
Catalogue references include 010.6110, 021.3410, 034.126, 034.362, 035.3012S, 035.3506S.
European nomenclature codes declared: P01020101, L159099, Q010699, P01020180, S010499, Z12011401.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | INSTITUT STRAUMANN AG (CH) · FDA 9613348 |
| Devices in EUDAMED | 2 449 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 2 449 |
|---|---|
| Found in the U.S. device database | 2 268 |
| Share | 92.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | INSTITUT STRAUMANN AG |
What it holds in Canada
| Licences on record | 96 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 31 |
| Class 3 devices | 63 |
| Class 4 devices | 2 |
| First licensed | 1998-10-23 |
Licence types: Device Family (58), System (21), Device Group Family (8), Single Device (6).
Licensed under: ALIGNMENT PINS, DEPTH GAUGES, AND IMPLANT DEPT, STRAUMANN TISSUE LEVEL TORCFIT IMPLANT SYSTEM, STRAUMANN BONE CERAMIC, CARES VARIOBASE SYSTEM, SINGLE USE DRILLS - TITANIUM ALLOY, STRAUMANN BONE LEVEL TAPERED IMPLANT SYSTEM.
North American profile: Both markets. Institut Straumann AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G11 020326 0063 | reissued | 2030-05-25 |
G10 020326 0062 | reissued | 2030-06-15 |