ACG Air & Gas Solutions SK s.r.o.
SK-MF-000019263 · Slovakia · Vaďovce
ACG Air & Gas Solutions SK s.r.o. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 5 |
|---|
Most frequent device types declared: PSA Oxygen generator.
Among these devices, 5 are declared active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| Country of registration | Slovakia |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
10000462533-PA-NoMA-SVK | issued | 2027-05-04 |