Alifax S.r.l.
IT-MF-000030029 · Italy · Nimis
Alifax S.r.l. is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- HB&L CARBAPENEMASE KIT
- HB&L ESBL SCREENING KIT
- HB&L MRSA KIT
- HB&L UROQUATTRO
- HB&L UROQUATTRO LIGHT
- MM GRAM NEG ID
- MM GRAM NEG RES
- MM GRAM POS NO STAPH
- MM GRAM POS STAPH
- POSITIVE CONTROL KIT
- ROLLER 20
- ROLLER 20X
Showing 12 of 17 declared devices.
Catalogue references include SI 1001.930-L, SI 1001.950, SI 1701.0101/5L, SI 1701.0101/L, SI 1701.0104/5L, SI 190.300.
European nomenclature codes declared: W0104080699, W02039080, W02029001, W0104080505, W01040699, W0104080506.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 17 |
| 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 | 17 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 17.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ALIFAX S.R.L. |
What it holds in Canada
| Licences on record | 8 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| First licensed | 2009-12-11 |
Licence types: System (4), Device Family (2), Test Kit (1), Single Device (1).
Licensed under: TEST1 2.0, HB&L UROQUATTRO ANALYZERS, URO-QUICK SCREENING KIT, HB&L CULTURE KIT, ALFRED 60/AST, ROLLER.
North American profile: Canada only. Alifax S.r.l. holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IQMS/00005/0v003 | supplemented | 2030-11-23 |