BIOTRONIK SE & Co. KG
DE-MF-000005049 · Germany · Berlin
BIOTRONIK SE & Co. KG is registered in the European database on medical devices as a manufacturer, with 50 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 32 |
|---|---|
| Class IIa | 13 |
| Class IIb | 4 |
| other | 1 |
Most frequent device types declared: Selectra, Temp. pacing cable, Diagnostic cable, HMSC, Ablation cable.
Among these devices, 43 are declared sterile, 7 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 | BIOTRONIK SE & CO. KG (DE) · FDA 9610139 |
| Devices in EUDAMED | 50 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G70 010275 0541 | issued | 2026-08-05 |
20363GB448260407 | amended | 2027-09-28 |
20363GB448250929 | issued | 2027-09-28 |
13290GB450230504A | issued | 2028-02-20 |