Manufacturer
Aerotel
IsraelLegal entities : Aerotel Medical Systems (1998) Ltd.
Markets : Ireland · Poland · United States
Approvals : EU – class IIa · United States (FDA) – 510(k) : 14 · class I, II · latest in 2004 · see on the FDA website
EU representative : AF Pharma Service Europe 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 |
|---|---|---|---|---|
| ECG holter recorders | Z12050403 |
|
IIa 93/42 | EUDAMED record Report an error |
| ECG data management systems | Z12059009 |
|
IIa 93/42 | EUDAMED record Report an error |
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