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EUDAMED last updated this device on Jul 26, 2024
803371701NEB6204244NEB6035 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by 3A HEALTH CARE S.r.l.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04015672113251803371701NEB6204244NEB6035(01)04015672113251
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
R060101COLD NEBULISATION SYSTEMSNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 12 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Jul 5, 2024 | Jul 5, 2029 |
| Belgium | Jul 5, 2024 | Jul 5, 2029 |
| Germany | Jul 5, 2024 | Jul 5, 2029 |
| Spain | Jul 5, 2024 | Jul 5, 2029 |
| France | Jul 5, 2024 | Jul 5, 2029 |
| Latvia | Jul 5, 2024 | Jul 5, 2029 |
| Poland | Jul 5, 2024 | Jul 5, 2029 |
| Romania | Jul 5, 2024 | Jul 5, 2029 |
| Sweden | Jul 5, 2024 | Jul 5, 2029 |
| Slovenia | Jul 5, 2024 | Jul 5, 2029 |
| Slovakia | Jul 5, 2024 | Jul 5, 2029 |
| XI | Jul 5, 2024 | Jul 5, 2029 |
IT-MF-000009298No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.