Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instrumentsCardiac telemetry instruments
Cardiac telemetry instruments - software accessories
EMDN code Z12050882
Manufacturers registered in Europe (EUDAMED) 1
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Medtronic FDA EU representative : Medtronic B.V. (Netherlands) | United States |
|
IIb MDR | EUDAMED record Report an error |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 5
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Boston Scientific Corp Present in Europe in other categories | United States | myLUX™ Patient App myLUX™ Patient Kit with mobile device LUX-Dx™ Clinic Assistant Kit with mobile device LUX-Dx™ Clinic Assistant Mobile Device LUX-Dx II+™ myLUX™ | K252593 (2025) |
| Biotronik, Inc. Present in Europe in other categories | United States | BioMonitor III BioMonitor IV BioMonitor IIIm BioMonitor Remote Assistant III | K261074 (2026) |
| St Jude Medical | United States | Merlin.net™ Assert-IQ™ | registered |
| ABBOTT MEDICAL Present in Europe in other categories | United States | – | K253516 (2025) |
| Abbott Laboratories Present in Europe in other categories | United States | – | K251221 (2025) |
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