Ottobock SE & Co. KGaA
DE-MF-000010487 · Germany · Duderstadt
Ottobock SE & Co. KGaA is registered in the European database on medical devices as a manufacturer, with 107 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 107 |
|---|
Most frequent device types declared: 2C6, 3R106, 3R6, 4R11, 4R21.
Devices declared under this manufacturer
- 3R106 Redesign Service
- Foam cover
- Loaner/Test Polycentric Knee
- Modular Knee Joint, pneumatic
- Modular Knee Joint, pneumatic - Service
- Modular Single Axis Knee Joint Service
- Patella Pro
- Polycentric Modular Knee Joint
- Polycentric Modular Knee Joint, Service
- Quickchange - Service, Test
- Quickchange Adapter
- Triton Footshell
Showing 12 of 107 declared devices.
Catalogue references include 2C6=L24/15S, 2C6=L25/4N, 2C6=L26/15N, 2C6=R24/4S, 3R106=OB, 3R106=P-S.
European nomenclature codes declared: Y062409, Y062412, Y061209.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 107 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 107 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Ottobock SE & Co. KGaA was not found in either the U.S. or the Canadian register.