ProSpon, spol. s r.o.
CZ-MF-000019992 · Czechia · Kladno
ProSpon, spol. s r.o. is registered in the European database on medical devices as a manufacturer, with 264 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 161 |
|---|---|
| Class IIb | 102 |
| Class I | 1 |
Among these devices, 23 are declared sterile, 103 implantable.
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 | 264 |
| 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 |
|---|---|---|
2026-MDR/TD-003 | issued | 2029-04-26 |
2026-MDR/QS-032 | issued | 2031-05-22 |
2026-MDR/QS-003 | issued | 2029-04-26 |