Manufacturer
Heartsine
Northern IrelandLegal entities : HeartSine Technologies Ltd
Markets : Northern Ireland · United States
Approvals : EU – class IIb · United States (FDA) – 510(k) : 6 · PMA : 1 · class III · latest in 2026 · see on the FDA website
- 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 |
|---|---|---|---|---|
| Defibrillators - consumables | Z12030585 |
|
IIb MDR | EUDAMED record Report an error |
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