Hamilton AG
CH-MF-000013585 · Switzerland · Bonaduz
Hamilton AG is registered in the European database on medical devices as a manufacturer, with 121 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 10104382, 137257, 235477, 235541, 235695.
Among these devices, 24 are declared sterile.
Authorised representative in the Union: Johner Medical GmbH.
Devices declared under this manufacturer
- CO-RE II Tips, black, sterile
- CO-RE II Tips, non-sterile
- CO-RE Tips, black, non-sterile
- CO-RE Tips, black, sterile
- Deep Well Plates
- Field Verification Kit
- FlipTube
- Greenline CO-RE II Tips, non-sterile
- Greenline CO-RE II Tips, sterile
- Microlab STAR IVD-R
- RIDA®UNITY
- Reagent Containers
Showing 12 of 121 declared devices.
Catalogue references include 10104382, 137257, 235477, 235541, 235695, 235843.
European nomenclature codes declared: W0580, W0503020202, W0503020201, W02060199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | HAMILTON CO. (US) · FDA 2915796 |
| Devices in EUDAMED | 121 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 121 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 1.7 % |
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. Hamilton AG is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 1774385-1 | issued | 2029-09-15 |