EU → US Device Access

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 has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa107

Most frequent device types declared: 2C6, 3R106, 8320N, 4R11, 3R6.

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 registerSimilar name found — unverified
Matched entryOttobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH (DE) · FDA 9616494
Devices in EUDAMED107
Country of registrationGermany
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Other manufacturers in Germany

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