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 IIb | 3 |
| Class IIa | 6 |
Most frequent device types declared: Austin Moore Hip Stem System, BA Hip Stem System, BET Hip Stem System, BQS Hip Stem System, Biotech Acetabular Cup System.
Among these devices, 6 470 are declared sterile, 6 472 implantable, 6 reusable.
Devices declared under this manufacturer
- Acetabular Fixation Screw
- Austin Moore Hip Prosthesis Narrow
- BA BIOTAN Lateralized (128°) Femoral Stem w. HA coating
- BA BIOTAN Modular Acetabular Press-fit shell MM w. TPS coating
- BA Revision Femoral Stem
- BET extended offset Stem w. TPS+HA coating
- BMM Modular Acetabular Inlay
- Biotech Modular Revision Hip - offset proximal component w. TPS coatin
- Modular Acetabular Inlay, 20 degrees
- Modular Acetabular Inlay, Lateralised (+4mm)
- Müller Acetabular Cup for Revision
- Müller Acetabular Cup, High Wall
Showing 12 of 6 478 declared devices.
Catalogue references include 011-1311-0002, 021-0103-6436, 021-0301-6036, 021-0402-4628, 022-2131-2228, 022-2142-3132.
European nomenclature codes declared: P090803010102, P090803040101, P090804010201, P0908030301, P090804010202, P090804030202.
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 |
Device-level evidence
| Devices with a numeric GTIN | 6 466 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIOTECH, INC. |
North American profile: Both markets. Biotech GmbH is registered in both the United States and Canada.