Nidacon International AB
SE-MF-000001933 · Sweden · Mölndal
Nidacon International AB is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 14 |
|---|
Most frequent device types declared: NO-100, PS90-100, PSB-100, PS80-100, PS100-1000K.
Among these devices, 12 are declared sterile.
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 | NIDACON INTERNATIONAL AB (SE) · FDA 9616005 |
| Devices in EUDAMED | 14 |
| Country of registration | Sweden |