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EUDAMED last updated this device on May 21, 2026
805415412HF0E8IT-MF-000023450805415412HT0FJOn the marketAMB DISTRIBUTION O2 2AFN MAN COMP805415412HK0EPOn the marketAMB DISTRIBUTION O2 2AFN MAN LONG805415412HK0EPOn the marketAMB DISTRIBUTION O2 2UNI MAN COMP805415412HK0EPOn the marketAMB DISTRIBUTION O2 2UNI MAN LONG805415412HK0EPOn the marketNo 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.1 warning recorded — scroll inside the panel to see all entries.
CW010Primary placement in Italy; available across 10 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Still on market | |
| Belgium | Still on market | |
| Germany | Still on market | |
| Spain | Still on market | |
| France | Still on market | |
| Croatia | Still on market | |
| Netherlands | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market | |
| Romania | Still on market |
(01)08053687010635
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.
Z12159099VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER