Updated 22 October 2026
In-vitro diagnostics distributors in Italy: 57 licensed establishments
The Bastion Hale Distributor Index lists 57 establishments in Italy whose registry records include in-vitro diagnostics: 26 with a channel role (importer, distributor, wholesaler or authorised representative), 6 registration holders without a channel role, and 25 registered as manufacturer or exporter only, out of 3,680 medical device establishments in Italy overall. The records come from EUDAMED, US FDA (openFDA), Health Canada and web, last seen on 23 October 2026.
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 25 | 44% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 7 | 12% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 13 | 23% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 49 | 86% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 3 | 5% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Italy
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
Top 20 in-vitro diagnostics establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | SENTINEL CH. S.p.A. Milano | Channel Importer, Registration holder, Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 128 | 67 | 0 | 63.9 | 4/5 |
| 2 | Liofilchem S.r.l. Roseto Degli Abruzzi, TE | Channel Authorised representative, Registration holder, Manufacturer | In-vitro diagnostics | 288 | 5 | 0 | 56.5 | 4/5 |
| 3 | INVENTIS S.r.l. Padova | Channel Importer, Registration holder, Manufacturer | General hospital and consumables, Ear, nose and throat, In-vitro diagnostics +2 more | 35 | 15 | 0 | 50.6 | 4/5 |
| 4 | STERIS S.r.l. Segrate MI | Channel Importer, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 171 | 3 | 0 | 47.9 | 4/5 |
| 5 | Instrumentation Laboratory SpA Milano | Channel Importer, Authorised representative, Manufacturer, Exporter | Cardiovascular, In-vitro diagnostics, Surgery and endoscopy | 117 | 2 | 0 | 47.5 | 4/5 |
| 6 | EUROSPITAL S.P.A. Trieste, Italy, TS | Channel Importer, Registration holder, Manufacturer | In-vitro diagnostics | 15 | 16 | 0 | 46.7 | 3/5 |
| 7 | Alifax S.r.l. Polverara, UD | Channel Importer, Registration holder, Manufacturer | In-vitro diagnostics | 19 | 9 | 0 | 45.4 | 4/5 |
| 8 | STEELCO S.P.A. RIESE PIO X, TV | Channel Importer, Registration holder, Manufacturer | General hospital and consumables, In-vitro diagnostics | 31 | 4 | 0 | 44.5 | 4/5 |
| 9 | Fidia farmaceutici S.p.A. Abano Terme, PD | Channel Importer, Registration holder, Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +1 more | 9 | 10 | 0 | 42.3 | 4/5 |
| 10 | DiaSorin Italia S.p.A. Saluggia | Channel Importer, Authorised representative, Manufacturer | In-vitro diagnostics | 58 | 1 | 0 | 40.9 | 4/5 |
| 11 | MEDESY srl maniago | Channel Importer, Manufacturer | Anaesthesia and respiratory, Dental, In-vitro diagnostics +2 more | 33 | 1 | 0 | 36.5 | 4/5 |
| 12 | Silfradent S.R.L. S.Sofia (FC) | Channel Importer, Manufacturer, Exporter | Dental, In-vitro diagnostics | 5 | 1 | 0 | 29.3 | 4/5 |
| 13 | F.L. Medical s.r.l. Unipersonale Torreglia (PD) | Channel Importer, Manufacturer | In-vitro diagnostics | 5 | 1 | 0 | 27.7 | 4/5 |
| 14 | HUMAN BRAIN WAVE SRL Torino | Channel Importer, Manufacturer | In-vitro diagnostics, Orthopaedics, spine and trauma, Surgery and endoscopy | 5 | 1 | 0 | 27.7 | 4/5 |
| 15 | MEDITALIA S.R.L.. PALERMO (PA) | Channel Importer, Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 5 | 1 | 0 | 27.7 | 4/5 |
| 16 | Aptaca S.p.A. Monza | Channel Importer, Manufacturer | In-vitro diagnostics | 3 | 1 | 0 | 25.6 | 4/5 |
| 17 | ELSE Solutions S.r.l. Trezzano sul Naviglio | Channel Importer, Authorised representative | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 0 | 0 | 12 | 25.1 | 4/5 |
| 18 | BIOSIGMA S.P.A. Cantarana di Cona (VE) | Channel Importer, Manufacturer | In-vitro diagnostics | 2 | 1 | 0 | 24.2 | 4/5 |
| 19 | Aurogene Srl Roma | Channel Importer | General hospital and consumables, In-vitro diagnostics, Imaging, radiology and radiotherapy | 0 | 0 | 16 | 23.9 | 4/5 |
| 20 | Technogenetics S.p.A MILAN | Channel Importer, Authorised representative, Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 23.7 | 4/5 |
Questions about in-vitro diagnostics distributors in Italy
How many in-vitro diagnostics distributors are there in Italy?
The Index counts 57 establishments in Italy with in-vitro diagnostics in their registry record, of which 26 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from EUDAMED, US FDA (openFDA), Health Canada and web and was last refreshed on 22 October 2026.
Who can hold a in-vitro diagnostics device registration in Italy?
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
How do I find a in-vitro diagnostics distributor in Italy?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Italy to reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a in-vitro diagnostics distributor in Italy?
A company that appears in a public regulatory registry with an address in Italy and whose linked device listings fall in the in-vitro diagnostics segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Italy
In-vitro diagnostics in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 49 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 49 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 14 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
- web (public register): 8 establishments, last seen 23 October 2026. Public register.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.