Löwenstein Medical SE & Co. KG
DE-MF-000006028 · Germany · Bad Ems
Löwenstein Medical SE & Co. KG is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 11 |
|---|---|
| Class IIb | 3 |
Among these devices, 3 are declared active.
Devices declared under this manufacturer
- Bonnets large
- Bonnets medium
- Bonnets small
- Bonnets x large
- Bonnets x small
- Bonnets xx large
- Bonnets xx small
- Bonnets xxx large
- LEONI 4
- LM Neonatal Testlung, Disposable
- LM Neonatal Testlung, Reusable
- Single use expiratory valve set
Showing 12 of 14 declared devices.
Catalogue references include 0200011, 0730000, nj1513-10e, nj1514-10e, nj1515-10e, nj1516-10e.
European nomenclature codes declared: R03010280, Z1203010101, Z1203010580, Z1203010503, Z1203010585.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 14 |
| 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 | 14 |
|---|---|
| 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 SE & Co. KG was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1011391-1 | issued | 2028-09-05 |