Thommen Medical AG
CH-MF-000016262 · Switzerland · Grenchen
Thommen Medical AG is registered in the European database on medical devices as a manufacturer, with 292 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 276 |
|---|---|
| Class IIa | 16 |
Among these devices, 2 are declared sterile, 276 implantable, 1 reusable.
Authorised representative in the Union: Thommen Medical Deutschland GmbH.
Catalogue references include 1.04.710, 1.04.761, 1.04.844, 2.03.741, 2.03.747, 4.03.041.
European nomenclature codes declared: P01020101, V0480, P01020180, V0499.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | THOMMEN MEDICAL, AG (CH) · FDA 3003184527 |
| Devices in EUDAMED | 292 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 292 |
|---|---|
| Found in the U.S. device database | 275 |
| Share | 94.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | THOMMEN MEDICAL AG |
What it holds in Canada
| Licences on record | 31 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 15 |
| Class 3 devices | 16 |
| First licensed | 2008-03-06 |
Licence types: Device Family (24), Device Group Family (5), System (1), Single Device (1).
Licensed under: BONE CONTOURING INSTRUMENT, ADAPTERS FOR HANDPIECE, SCREWDRIVERS FOR HANDPIECE, EXPLANTATION DRILLS, CONTACT PROFILE DRILLS, SPI VECTODRILL TWIST DRILLS.
North American profile: Both markets. Thommen Medical AG is registered in both the United States and Canada.