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.
Devices declared under this manufacturer
- OXYMAT
Catalogue references include PSA Oxygen generator O10, PSA Oxygen generator O20, PSA Oxygen generator O280, PSA Oxygen generator O40, PSA Oxygen generator O60.
European nomenclature codes declared: R9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| Country of registration | Slovakia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. ACG Air & Gas Solutions SK s.r.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
10000462533-PA-NoMA-SVK | issued | 2027-05-04 |