Hyris Srl
IT-MF-000031635 · Italy · Milano
Hyris Srl is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: BKIT VIRUS FINDER COVID-19, BKIT VIRUS FINDER COVID-19 Saliva, HK038X050, HK043X020, HyCT16.01-25.
Devices declared under this manufacturer
- BKIT VIRUS FINDER COVID-19
- BKIT VIRUS FINDER COVID-19 Saliva
- CARTUCCIA CON 16 POZZETTI/16-WELLS CARTRIDGE
- CARTUCCIA CON 36 POZZETTI/36-WELLS CARTRIDGE
- NL SOLUTION
- NL SOLUTION (Prefilled)
- XTACT SCV2 T Activation
- bCUBE 2.0
- bCUBE3
- bKIT Immunofinder dqTACT MS
Showing 12 of 16 declared devices.
Catalogue references include H0001, HK038X100, HK043X020, HyCT16.01-25, bAPP, bCUBE 2.0.
European nomenclature codes declared: W0105040519, W01030699, W0105900201, W02050185, W02050116, W02050182.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 16 |
| 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 | 16 |
|---|---|
| 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. Hyris Srl was not found in either the U.S. or the Canadian register.