Biotech GmbH
DE-MF-000023586 · Germany · Rheinbrohl
Biotech GmbH is registered in the European database on medical devices as a manufacturer, with 6 478 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 6 469 |
|---|---|
| Class IIa | 6 |
| Class IIb | 3 |
Most frequent device types declared: Biotech Acetabular Cup System, BA Hip Stem System, SKM Hip Stem System, Biotech Modular Head System, Biotech Modular Revision Hip Stem System.
Among these devices, 6 470 are declared sterile, 6 472 implantable, 6 reusable.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BIOTECH, INC. (US) · FDA 3010781586 |
| Devices in EUDAMED | 6 478 |
| Country of registration | Germany |