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 IIa | 13 |
|---|---|
| Class I | 32 |
| Class IIb | 4 |
Most frequent device types declared: Ablation cable, Diagnostic cable, HMSC, Qubic Stim, Reocor S/D.
Among these devices, 43 are declared sterile, 7 active.
Devices declared under this manufacturer
- MPK-10-R/2,0 m
- PK-112
- Qubic Stim - EP Heart Stimulator
- Reocor D
- Reocor S
- SW HMSC 3.66
- Selectra 3D-40-42
- Selectra 3D-55-39
- Selectra BIO2-45
- Selectra Extended Hook-45
- Selectra Hook-55
- Selectra IC-90-69
Showing 12 of 50 declared devices.
Catalogue references include 353173, 375523, 375527, 375530, 375534, 392292.
European nomenclature codes declared: C0502, Z12050680, C020180, J010792, Z12059080, Z1205078001.
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 |
Device-level evidence
| Devices with a numeric GTIN | 49 |
|---|---|
| Found in the U.S. device database | 41 |
| Share | 83.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIOTRONIK SE & CO. KG |
What it holds in Canada
| Licences on record | 43 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 15 |
| Class 3 devices | 14 |
| Class 4 devices | 14 |
| First licensed | 2002-10-16 |
Licence types: Device Family (20), Single Device (11), System (10), Device Group Family (2).
Licensed under: LEAD STYLETS, ICS 3000 PROGRAMMING AND MONITORING SYSTEM, IMPLANTABLE PACING LEADS (STEROID ELUTING), DH (FIXATION TOOL), TW (SCREWDRIVER), M-50 (MAGNET).
North American profile: Both markets. BIOTRONIK SE & Co. KG is registered in both the United States and Canada.
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 |