Updated 22 October 2026
Ophthalmic device distributors in Italy: 145 licensed establishments
The Bastion Hale Distributor Index lists 145 establishments in Italy whose registry records include ophthalmic: 32 with a channel role (importer, distributor, wholesaler or authorised representative), 2 registration holders without a channel role, and 111 registered as manufacturer or exporter only, out of 3,680 medical device establishments in Italy overall. The records come from US FDA (openFDA), EUDAMED, Health Canada and web, last seen on 23 October 2026.
Ophthalmic covers intraocular lenses, diagnostic and surgical equipment, contact lenses and vision care. Buyers are eye hospitals, day surgery centres and optical retail, each with its own distributors. Intraocular lenses are a tender-driven, high-volume line in most public systems.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 10 | 7% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 17 | 12% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 8 | 6% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 4 | 3% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 112 | 77% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 56 | 39% | 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 ophthalmic 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 | FIAB S.p.A. Vicchio, FI | Channel Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Patient monitoring and neurology +2 more | 18 | 9 | 0 | 46.4 | 4/5 |
| 2 | ESPANSIONE MARKETING S.P.A. FUNO DI ARGELATO, BO | Channel Importer, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Patient monitoring and neurology, Ophthalmic +1 more | 14 | 5 | 0 | 41.5 | 4/5 |
| 3 | Luxottica Group S.P.A. Milano | Channel Importer, Distributor, Authorised representative, Manufacturer, Exporter | Ear, nose and throat, Ophthalmic | 12 | 3 | 0 | 38.7 | 3/5 |
| 4 | GENERAL TRADING & SERVICES S.R.L. Mascalucia | Channel Importer, Exporter | Ophthalmic | 22 | 1 | 0 | 34.5 | 3/5 |
| 5 | AKTIVE SRL ROME | Channel Importer, Manufacturer | Ophthalmic | 10 | 1 | 0 | 30.7 | 4/5 |
| 6 | POLINELLI S.R.L. Daverio (VA) | Channel Importer, Manufacturer | Ophthalmic | 6 | 1 | 0 | 28.5 | 4/5 |
| 7 | De Rigo Vision S.p.A. Longarone (BL) | Channel Authorised representative, Manufacturer, Exporter | Ophthalmic | 4 | 1 | 0 | 28.4 | 3/5 |
| 8 | EPOS srl Milano | Channel Distributor, Manufacturer, Exporter | Ophthalmic | 3 | 1 | 0 | 27.2 | 4/5 |
| 9 | AERIAL VISION INTERNATIONAL SPA ROME | Channel Importer, Manufacturer, Exporter | Ophthalmic | 2 | 1 | 0 | 25.8 | 4/5 |
| 10 | MAD IN ITALY S.R.L ALANO DI PIAVE | Channel Distributor, Manufacturer, Exporter | Ophthalmic | 2 | 1 | 0 | 25.8 | 4/5 |
| 11 | Carlo Sestini S.R.L. Milano | Channel Distributor, Manufacturer, Exporter | Ophthalmic | 2 | 1 | 0 | 25.8 | 3/5 |
| 12 | Cutler and Gross S.r.l. Domegge di Cadore | Channel Authorised representative, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 4/5 |
| 13 | DI ESSE S.R.L. domegge di cadore | Channel Distributor, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 4/5 |
| 14 | L.G.R srl Roma | Channel Authorised representative, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 4/5 |
| 15 | OFHK EUROPE SRL TREVISO | Channel Authorised representative, Exporter | Ophthalmic | 2 | 1 | 0 | 24.2 | 4/5 |
| 16 | Più Forty S.r.l. Prato | Channel Distributor, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 4/5 |
| 17 | ALEX OCCHIALI SRL Treviso (TV) | Channel Distributor, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 3/5 |
| 18 | PUMAK TRADING S.R.L. UDINE | Channel Distributor, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 3/5 |
| 19 | STAR LIGHT S.R.L. VALDOBBIADENE | Channel Distributor, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 3/5 |
| 20 | Vision Up and Logoservice S.r.l. Roma | Channel Importer, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 3/5 |
Questions about ophthalmic distributors in Italy
How many ophthalmic distributors are there in Italy?
The Index counts 145 establishments in Italy with ophthalmic in their registry record, of which 32 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA), EUDAMED, Health Canada and web and was last refreshed on 22 October 2026.
Who can hold a ophthalmic 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 ophthalmic 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 ophthalmic 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 ophthalmic 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
Ophthalmic in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 143 establishments, last seen 22 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 65 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 4 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
- web (public register): 2 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.