Establishment registration
Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH
FDA establishment registration 9616494 · DUDERSTADT Lower Saxony, DE
Key facts
| Registration number | 9616494 |
|---|---|
| Establishment name | Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH |
| Owner/operator | Ottobock SE & Co. KGaA |
| Owner/operator number | 8010097 |
| FEI number | 3003117657 |
| Address | Max-Naeder-Strasse 15 |
| City | DUDERSTADT Lower Saxony |
| Country | DE |
| Registration valid through | 2026 |
| Product codes listed | EXN, GXY, ILE, ILH, IOY, IPM, IPR, IPS, IPT, IPW, IPY, IQE, IQI, IQK, IQO, IQQ, IQW, IQX, IQZ, IRA, IRD, IRE, ISH, ISL, ISP, ISR, ISS, ISY, ISZ, ITC and 9 more |
| Device classes | 1, 2 |
At a glance
- 10–99 Device listings
- 100–999 UDI devices (GUDID)
- Current Registration current
- 1–9 FDA inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device establishment registrations
Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database