Novotec Medical GmbH
DE-MF-000015364 · Germany · Pforzheim
Novotec Medical GmbH is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 25 |
|---|
Among these devices, 20 are declared active.
Devices declared under this manufacturer
- Galileo Delta A
- Galileo Delta C
- Galileo Mano Med (Control)
- Galileo Mano Med 20L
- Galileo Mano Med 30
- Galileo Med 15
- Galileo Med 25
- Galileo Med 25 H
- Galileo Med 35
- Galileo Med Fit Extreme
- Galileo Med Fit Extreme Sensor
- Galileo Med Fit Sensor
Showing 12 of 25 declared devices.
Catalogue references include 0404 xy, 0415 xy, 0506 1y, 0508 51, 0508 55, 0555 30.
European nomenclature codes declared: Z12062899.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NOVOTEC MEDICAL GMBH (DE) · FDA 3002761514 |
| Devices in EUDAMED | 25 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 25 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NOVOTEC MEDICAL GMBH |
North American profile: Both markets. Novotec Medical GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 044939 0014 | issued | 2028-09-04 |