GAMA GROUP a.s.
CZ-MF-000011894 · Czechia · České Budějovice
GAMA GROUP a.s. is registered in the European database on medical devices as a manufacturer, with 259 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 215 |
|---|---|
| other | 44 |
Most frequent device types declared: Láhev na moč s uzávěrem.
Among these devices, 219 are declared sterile.
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 | 259 |
| Country of registration | Czechia |
⚠️ 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 |
|---|---|---|
26 0129 QR/NB | issued | 2031-04-29 |
23 0517 QR/NB | issued | 2028-11-09 |