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: PFHM731, BFE99, PFHM931, PFHM933, PFHM722.
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 | 611 |
| 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.