Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signsVarious instruments to support and monitor vital signs
Various instruments to support and monitor vital signs - medical device software
EMDN code Z12039092
Manufacturers registered in Europe (EUDAMED) 22
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 1
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 |
|---|---|---|---|
| Samsung Electronics Co., Ltd. Present in Europe in other categories | South Korea | Samsung ECG App v 1.3 (ECG) Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | registered |
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