Manufacturer
Garmin
United StatesLegal entities : Garmin International, Inc.
Markets : Netherlands · United States
Approvals : EU – class IIa · United States (FDA) – 510(k) : 1 · class II · latest in 2023 · see on the FDA website
EU representative : Emergo Europe B.V. (Netherlands)
- 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 |
|---|---|---|---|---|
| Electrocardiographs - medical device software | Z12050392 |
|
IIa 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.
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