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
| Class IIa | 66 |
|---|
Most frequent device types declared: ACIDO ACETICO, ALCOOL ETILICO, ANSE CALIBRATE, CONTENITORE PRECARICATO CON FORMALDEIDE 4%, CONTENITORI PER CAMPIONI ISTOLOGICI.
Among these devices, 17 are declared sterile, 7 active.
Devices declared under this manufacturer
- ACIDO ACETICO 1% p/v/ ACETIC ACID 1% w/v 500 ml
- ACIDO ACETICO 3% p/p/ ACETIC ACID 3% w/w 500 ml
- ANSA NI-CR µl 10 ø 4,8
- BOTTIGLIA DIURESI 24 ORE tipo tondo
- CONTENITORE HDPE TAPPO VITE 180 ml
- CONTENITORE PER TISSUE VACUUM PLUS 5000 ml
- CONTENITORE PP TAPPO PRESSIONE CHIUSURA ERMETICA 5 lt
- CONTENITORE PP TAPPO PRESSIONE SERIGRAFATO 2000 ml
- CONTENITORE PP TAPPO PRESSIONE SERIGRAFATO 250 ml
- CONTENITORE PP TAPPO PRESSIONE TRASPARENTE 3000 ml
- CONTENITORE PS TAPPO PRESSIONE 20 ml
- GHIACCIO IN GEL KRYO GEL 14 x 18 cm
Showing 12 of 201 declared devices.
Catalogue references include 0104, 0131, 0405, 0645, 1002, 2827.
European nomenclature codes declared: W050301029099, Y091299, W01030799, W0503010203, U089006, M010103.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 201 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 201 |
|---|---|
| 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. Kaltek S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT348898 | issued | 2030-01-12 |
0425-MDR-030116-00 | issued | 2030-01-08 |