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 IIa | 3 |
|---|---|
| Class IIb | 7 |
Most frequent device types declared: Hardware related accessories, LEOBRAIN, LEOCAP, Single Use Valve bar, elisa 300/500.
Among these devices, 8 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- Angled Hose Adapter Single Use Expiration
- Expiration Flow Sensor elisa 300/500
- LEOBRAIN
- LEOCAP
- elisa 300
- elisa 500
- elisa 600
- elisa 600 R-VIT
- elisa 800
- elisa 800 R-VIT
Catalogue references include AG-370601, AG-370830, AG-370831, AG-480500, AZ-480100, AZ-480400.
European nomenclature codes declared: Z1203010504, Z1203010580.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 10 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 10 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. Löwenstein Medical Innovation GmbH & Co. KG was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 012094 0035 | supplemented | 2031-08-05 |