Biotronik AG
CH-MF-000010176 · Switzerland · Bülach
Biotronik AG is registered in the European database on medical devices as a manufacturer, with 370 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 370 |
|---|
Among these devices, 370 are declared sterile.
Authorised representative in the Union: Teleflex Medical.
Devices declared under this manufacturer
- Oscar
- Oscar PTA
- Passeo-14
- Passeo-18
- Passeo-35 Xeo
Showing 12 of 370 declared devices.
Catalogue references include 357452, 357459, 366123, 376303, 428779, 428787.
European nomenclature codes declared: C010402020101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BIOTRONIK AG (CH) · FDA 8043892 |
| Devices in EUDAMED | 370 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 370 |
|---|---|
| Found in the U.S. device database | 370 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIOTRONIK AG |
What it holds in Canada
| Licences on record | 11 |
|---|---|
| Currently active | 0 |
| Class 4 devices | 11 |
| First licensed | 2010-06-24 |
Licence types: Device Family (7), Device Group Family (3), Single Device (1).
Licensed under: PANTERA LEO FAST-EXCHANGE PTCA CATHETER, PASSEO-18 PERIPHERAL DILATATION CATHETER, PASSEO-14 PERIPHERAL DILATATION CATHETER, PANTERA LUX PACLITAXEL RELEASING PTCA BALLOON , PANTERA PRO CORONARY DILATATION CATHETER, PK PAPYRUS COVERED CORONARY STENT SYSTEM.
North American profile: Both markets. Biotronik AG is registered in both the United States and Canada.