Andreas Hettich GmbH
DE-MF-000010680 · Germany · Tuttlingen
Andreas Hettich GmbH is registered in the European database on medical devices as a manufacturer, with 112 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 25 |
|---|
Most frequent device types declared: 1206, 1801, 2200, 2205, 2350, 3700, 3704.
Among these devices, 25 are declared active.
Devices declared under this manufacturer
- BOECO HC-240 - 100-127V/50-60Hz
- HAEMATOKRIT 200 - 100-127V/50-60HZ
- HettCube 400, 220-240V, 50/60 Hz
- MIKRO 220 R, 100-127V/60Hz
- MIKRO 220 Robotic 200-240V/50-60Hz
- ROTANTA 460 R, 100-127V 60Hz 100V 50Hz
- ROTANTA 460 Robotic, 110-120V 50-60Hz
- ROTANTA 460 Robotic, 200-220V 50-60Hz
- ROTANTA 460 Robotic, 230-240V 50-60Hz
- ROTINA 380 RC Robotic
- ROTINA 420 R, 200-240V 50Hz
- ROTIXA 500 RS, 230-240V 50Hz + 220V 60Hz
Showing 12 of 112 declared devices.
Catalogue references include 1801-12, 2205-01, 2350, 5660-51, 5680-40, 5680-48.
European nomenclature codes declared: W02069005, W02069003, W02039002.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ANDREAS HETTICH GMBH (DE) · FDA 3005990076 |
| Devices in EUDAMED | 112 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 112 |
|---|---|
| Found in the U.S. device database | 42 |
| Share | 37.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ANDREAS HETTICH GMBH |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2016-08-26 |
Licence types: Single Device (2).
Licensed under: ROTO SILENTA 630RS, ROTIXA 500RS.
North American profile: Both markets. Andreas Hettich GmbH is registered in both the United States and Canada.