Lothar Medtec GmbH
DE-MF-000007469 · Germany · Würzburg
Lothar Medtec GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 |
|---|
Most frequent device types declared: ALDS, ALDS Hardware Accessories, Treatment Optimiser.
Among these devices, 8 are declared active, 8 with a measuring function.
Devices declared under this manufacturer
- ALDM FENO
- ALDM SPIRO
- ALDS
- ALDS PRO
- ALDS Software
- Asthma Optimiser
Catalogue references include ALDM FENO, ALDM SPIRO, ALDS, ALDS PRO, ALDS Software, ALDS-Accessories.
European nomenclature codes declared: Z12159080, Z12159092, Z12159082.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LOTHAR MEDTEC GMBH (DE) · FDA 3019585254 |
| Devices in EUDAMED | 8 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LOTHAR MEDTEC GMBH |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2022-12-14 |
Licence types: System (1).
Licensed under: ALDS AMBULATORY LUNG DIAGNOSE SYSTEM.
North American profile: Both markets. Lothar Medtec GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 102194 0006 | amended | 2030-07-31 |