Updated 23 October 2026
In-vitro diagnostics distributors in Italy: 57 licensed establishments
Italy has 5 independent distributors in the Index so far.
The Bastion Hale Distributor Index lists 57 establishments in Italy whose registry records include in-vitro diagnostics: 5 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 21 manufacturers' own import or sales entities, 0 regulatory representatives, and 31 manufacturers or exporters, out of 3,728 medical device establishments in Italy overall. The records come from EUDAMED, US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 October 2026.
Listed
Independent distributors in the Index here, ranked by the lines each distributor carries, then registrations, then size.
- 1Aurogene SrlRoma16 lines0 registrationssize 20.5
- 2A. De Mori S.p.A.MILANO4 lines0 registrationssize 15.8
- 3CABRU S.a.s. di Bruno Casagrande e C.BIASSONO (MB)3 lines0 registrationssize 15.0
- 4ELSE Solutions S.r.l.Trezzano sul Naviglio2 lines0 registrationssize 16.1
- 5BIOMED SRLGENOVA1 line0 registrationssize 14.6
Include manufacturers, their own sales entities and regulatory representatives (52)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
- 15 lines0 registrationssize 16.5
- 2DiaSorin Italia S.p.A.Saluggia, VC0 lines109 registrationssize 65.3
- 3SENTINEL CH. S.p.A.Milano, Lombardia0 lines103 registrationssize 67.7
- 4EUROSPITAL S.P.A.Trieste, Italy, TS0 lines30 registrationssize 51.4
- 5INVENTIS S.r.l.Padova0 lines19 registrationssize 53.5
- 6Liofilchem S.r.l.Roseto Degli Abruzzi, TE0 lines12 registrationssize 62.0
- 7Alifax S.r.l.Polverara, UD0 lines10 registrationssize 47.7
- 8Fidia farmaceutici S.p.A.Abano Terme, PD0 lines10 registrationssize 44.2
- 9STEELCO S.P.A.RIESE PIO X, TV0 lines9 registrationssize 49.6
- 10Technogenetics S.p.AMILAN, Giornate0 lines6 registrationssize 37.6
- 110 lines4 registrationssize 52.3
- 12STERIS S.r.l.Segrate MI0 lines3 registrationssize 47.9
- 13MEDITALIA S.R.L..PALERMO (PA)0 lines2 registrationssize 32.0
- 14Aptaca S.p.A.Monza0 lines2 registrationssize 29.9
- 15BIOSIGMA S.P.A.Cantarana di Cona (VE), Venice0 lines2 registrationssize 28.5
- 16MEDESY srlmaniago0 lines1 registrationsize 38.9
- 17HUMAN BRAIN WAVE SRLTorino0 lines1 registrationsize 30.1
- 18Silfradent S.R.L.S.Sofia (FC)0 lines1 registrationsize 29.3
- 19F.L. Medical s.r.l. UnipersonaleTorreglia (PD)0 lines1 registrationsize 27.7
- 200 lines0 registrationssize 11.9
See Germany: 888 independent distributors
Distributor in Italy? Add your company, free
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.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later. The Next 10 Markets report covers who holds the registration in each of your ten markets.
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 5 are independent distributors (a channel role and no manufacturing of their own). The number comes from EUDAMED, US FDA (openFDA), MHRA UK and Health Canada and was last refreshed on 23 October 2026.
Who can hold an 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 an 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 see the top three names. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as an 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 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 28 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 14 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 8 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.