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.
Devices declared under this manufacturer
- MAGIC Microcatheter
Catalogue references include MA1.2FOLIVE, MA1.5FMP, MA1.5FOLIVEMP, MAGIC1.2FM, MAGIC1.2FM180, MAGIC1.5F.
European nomenclature codes declared: C0104020101,C0104020202,C0104020205, C0104020101,C0104020102,C0104020205.
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 |
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BALT EXTRUSION SAS |
What it holds in Canada
| Licences on record | 17 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 15 |
| Class 4 devices | 2 |
| First licensed | 2003-04-23 |
Licence types: Device Family (9), Device Group Family (6), Single Device (2).
Licensed under: SILK INTRACRANIAL SELF-EXPANDING STENTS, MAGIC-FLOW-DEPENDANT MICROCATHETER WITH PROGRE, BALTACCI - INTRACEREBRAL MICROCATHETER WITH SU, MAGIC CATHETER BALLOON INTRODUCER, SONIC - BRAIDED MICROCATHETER WITH PROGRESSIVE, VASCO+ REINFORCED CATHETERS.
North American profile: Both markets. Balt extrusion SAS is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
170779129 | issued | 2027-09-01 |
170779128 | issued | 2027-09-01 |