Balt extrusion SAS
FR-MF-000007563 · France · Montmorency
Balt extrusion SAS is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 9 |
|---|
Among these devices, 9 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 | BALT EXTRUSION (FR) · FDA 8023054 |
| Devices in EUDAMED | 9 |
| Country of registration | France |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
170779129 | issued | 2027-09-01 |
170779128 | issued | 2027-09-01 |