Balerina-Czech, s.r.o.
CZ-MF-000050806 · Czechia · Mnichovo Hradiště
Balerina-Czech, s.r.o. is registered in the European database on medical devices as a manufacturer, with 611 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 611 |
|---|
Most frequent device types declared: BFE99, PFHM722, PFHM731, PFHM931, PFHM933.
Devices declared under this manufacturer
- Jednorázová rouška Balerina BFE99
- Respirator Balerina PFHM722, economy edition
- Respirator Balerina PFHM731
- Respirator Balerina PFHM931
- Respirator Balerina PFHM933
Showing 12 of 611 declared devices.
Catalogue references include 8594205373066, 8594205373806, 8594205374032, 8594205374841, 8594205375305, 8594205376593.
European nomenclature codes declared: T020699, T020604.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 611 |
| 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 | 611 |
|---|---|
| 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. Balerina-Czech, s.r.o. was not found in either the U.S. or the Canadian register.