Nobel Biocare AB
SE-MF-000000009 · Sweden · Göteborg
Nobel Biocare AB is registered in the European database on medical devices as a manufacturer, with 3 516 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 2 307 |
|---|---|
| Class IIa | 1 209 |
Most frequent device types declared: 29066, 29067, 29004, 29010, 29064.
Among these devices, 1 070 are declared sterile, 2 277 implantable, 419 reusable, 27 active.
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 | NOBEL BIOCARE AB (SE) · FDA 9611992 |
| Devices in EUDAMED | 3 516 |
| Country of registration | Sweden |