Manufacturer
ATsens
South KoreaLegal entities : ATsens Co., Ltd.
Markets : Germany · Greece · Romania · Spain · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 2 · class II · latest in 2025 · see on the FDA website
EU representative : CMC Medical Devices & Drugs SL (Spain)
- 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 |
|---|---|---|---|---|
| Cardiovascular holter analysers | Z12050401 |
|
IIa 93/42 | EUDAMED record Report an error |
| Holter system instruments for cardiovascular parameters - consumables | Z12050485 | I 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.
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.