Manufacturer
Biotronik
GermanyLegal entities : BIOTRONIK SE & Co. KG
Markets : Belgium · Denmark · Estonia · Finland · France · Germany · Italy · Netherlands · Poland · Spain · Sweden · United States
Approvals : EU – class I, IIb · United States (FDA) – 510(k) : 145 · PMA : 11 · class I, II, III · latest in 2026 · see on the FDA website
Public contracts won : France 266 · Spain 103 · Italy 55 · Sweden 9 · Finland 6 · Belgium 5 · Poland 5 · Estonia 2 · Netherlands 2 · Denmark 1
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Cardiac electrophysiology stimulators | Z1205078001 | IIb MDR | EUDAMED record Report an error | |
| Instruments for cardiological polygraphy - hardware accessories - other | Z1205078099 | I MDR | EUDAMED record Report an error | |
| Invasive cardiac stimulators | Z12050602 |
|
IIb MDR | EUDAMED record Report an error |
| Non-implantable cardiac stimulators - hardware accessories | Z12050680 | I MDR | EUDAMED record Report an error | |
| Various instruments for cardiology and cardiac surgery - hardware accessories | Z12059080 |
|
I MDR | EUDAMED record Report an error |
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