Löwenstein Medical Innovation GmbH & Co. KG
DE-MF-000016838 · Germany · Steinbach (Taunus)
Löwenstein Medical Innovation GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 7 |
|---|---|
| Class IIa | 3 |
Most frequent device types declared: elisa 600/800, elisa 300/500, Hardware related accessories, LEOBRAIN, LEOCAP.
Among these devices, 8 are declared active, 2 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 10 |
| Country of registration | Germany |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 012094 0035 | supplemented | 2031-08-05 |