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 |
|---|
Most frequent device types declared: Láhev na moč s uzávěrem.
Among these devices, 219 are declared sterile.
Devices declared under this manufacturer
- Cievka Nelaton s 2 BO, M, 2,67mm (Ch 8) x 400 mm
- Cievka Nelaton s 2 BO, M, 6,67mm (Ch 20) x 400 mm
- Cievka odsávacia s CO, 1 BO, 4mm (Ch 12) x 400 mm
- Cievka rektálna s CO, 8,3mm (Ch 25) x 300 mm
- Cévka pro výživu novorozence CV-01 M
- GAMAPLUS® 3,0 x 150 LCH M
- Infúzna súprava IS-126T – 62 ShA
- Kyreta aspiračná 8mm x 200mm
- Kónická odměrka na moč 100 ml - modrá
- Láhev na moč s uzávěrem - zelená
- Nosová odsávačka - modrá
- Prevodová súprava PS
Showing 12 of 259 declared devices.
Catalogue references include V204811-54, V606321-ND, V606372-M, V606386-03ND, V646610-ND, V646616-ND.
European nomenclature codes declared: A03020101, G020301, W0503030101, R010499, A03040199, U01010502.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 259 |
| Country of registration | Czechia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 259 |
|---|---|
| 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. GAMA GROUP a.s. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
26 0129 QR/NB | issued | 2031-04-29 |
23 0517 QR/NB | issued | 2028-11-09 |