ALFAMEDIC s.r.o.
CZ-MF-000037764 · Czechia · Lišov (okres České Budějovice)
ALFAMEDIC s.r.o. is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 16 |
|---|---|
| Class IIa | 10 |
Most frequent device types declared: ALFANEST, FL-2010, HM-13, MINI, VL-22 / VL-22F.
Among these devices, 24 are declared active, 17 with a measuring function.
Devices declared under this manufacturer
- Heated Bowl VMO-06
- Heated bed for newborns and infants VL-22
- Heated pad HM-13
- Newborn bed ALFANEST
- Newborn bed MINI
- Phototherapy lamp FL-2010
Showing 12 of 26 declared devices.
Catalogue references include FL-2010, HM-13 M, HM-13 V, VL-22-G-M, VL-22-S-B, VL-22-S-M.
European nomenclature codes declared: Z12080407, V0899, Z12040208, Z12080401.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 26 |
| 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 | 26 |
|---|---|
| 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. ALFAMEDIC s.r.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2025-MDR/QS-031 | issued | 2030-06-03 |