Kaltek S.r.l.
IT-MF-000019573 · Italy · Saonara (PD)
Kaltek S.r.l. is registered in the European database on medical devices as a manufacturer, with 201 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| other | 135 |
|---|---|
| Class IIa | 66 |
Most frequent device types declared: CONTENITORI PER CAMPIONI ISTOLOGICI, CUVETTE, PADELLA PLURIUSO, CONTENITORE PRECARICATO CON FORMALDEIDE 4%, PAPPAGALLO.
Among these devices, 17 are declared sterile, 7 active.
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 | 201 |
| Country of registration | Italy |
⚠️ 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 |
|---|---|---|
IT348898 | issued | 2030-01-12 |
0425-MDR-030116-00 | issued | 2030-01-08 |