Updated 22 October 2026
Ophthalmic device distributors in Italy: 148 licensed establishments
The Bastion Hale Distributor Index lists 148 establishments in Italy whose registry records include ophthalmic: 6 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 26 manufacturers' own import or sales entities, 1 regulatory representatives, and 115 manufacturers or exporters, out of 3,728 medical device establishments in Italy overall. The records come from US FDA (openFDA), EUDAMED, MHRA UK and Health Canada, 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 | 11 | 7% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 17 | 11% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 8 | 5% | 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 | 116 | 78% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 56 | 38% | 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 6 independent ophthalmic distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | DIPO S.r.l. Roma | Distributor Importer | Aesthetics, dermatology and lasers, General hospital and consumables, Ear, nose and throat +3 more | 0 | 0 | 1 | 12.3 | 4/5 |
| 2 | GENERAL TRADING & SERVICES S.R.L. Mascalucia | Distributor Importer, Exporter | Ophthalmic | 22 | 1 | 0 | 34.5 | 3/5 |
| 3 | OWENSCORP ITALIA SPA SAN GIACOMO DELLE SEGNATE Mantova | Distributor Distributor, Exporter | Dental, Ophthalmic | 2 | 1 | 0 | 20.8 | 3/5 |
| 4 | VISION TRADE Srl CASALSERUGO Padova | Distributor Distributor, Exporter | Ophthalmic | 2 | 1 | 0 | 20.8 | 3/5 |
| 5 | NOMEC 92 SRL VENEGONO SUPERIORE Varese | Distributor Distributor | Ophthalmic | 2 | 1 | 0 | 18.5 | 3/5 |
| 6 | PAGANI SRL Lomazzo Como | Distributor Distributor | Ophthalmic | 2 | 1 | 0 | 18.5 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (142)
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.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | FIAB S.p.A. Vicchio, FI | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Patient monitoring and neurology +2 more | 18 | 17 | 0 | 51.0 | 4/5 |
| 2 | ESPANSIONE MARKETING S.P.A. FUNO DI ARGELATO, BO | Maker's own entity Importer, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Patient monitoring and neurology, Ophthalmic +1 more | 14 | 8 | 0 | 45.3 | 4/5 |
| 3 | Luxottica Group S.P.A. Milano | Maker's own entity Importer, Distributor, Authorised representative, Manufacturer, Exporter | Ear, nose and throat, Ophthalmic | 12 | 4 | 0 | 42.2 | 3/5 |
| 4 | OMISAN FARMACEUTICI S.R.L. Guidonia Montecelio | Maker's own entity Importer, Manufacturer | Ophthalmic | 4 | 4 | 0 | 31.1 | 4/5 |
| 5 | AKtive S.r.l.. ROME | Maker's own entity Importer, Manufacturer | Ophthalmic | 10 | 1 | 0 | 33.2 | 4/5 |
| 6 | EPOS srl. Milano | Maker's own entity Distributor, Manufacturer, Exporter | Ophthalmic | 3 | 1 | 0 | 29.6 | 4/5 |
| 7 | POLINELLI S.R.L. Daverio (VA) | Maker's own entity Importer, Manufacturer | Ophthalmic | 6 | 1 | 0 | 28.5 | 4/5 |
| 8 | De Rigo Vision S.p.A. Longarone (BL) | Maker's own entity Authorised representative, Manufacturer, Exporter | Ophthalmic | 4 | 1 | 0 | 28.4 | 3/5 |
| 9 | AERIAL VISION INTERNATIONAL SPA ROME | Maker's own entity Importer, Manufacturer, Exporter | Ophthalmic | 2 | 1 | 0 | 25.8 | 4/5 |
| 10 | MAD IN ITALY S.R.L ALANO DI PIAVE | Maker's own entity Distributor, Manufacturer, Exporter | Ophthalmic | 2 | 1 | 0 | 25.8 | 4/5 |
| 11 | Carlo Sestini S.R.L. Milano | Maker's own entity Distributor, Manufacturer, Exporter | Ophthalmic | 2 | 1 | 0 | 25.8 | 3/5 |
| 12 | THELIOS S.P.A. Longarone, Belluno | Maker's own entity Authorised representative, Manufacturer | Ophthalmic | 1 | 1 | 0 | 24.5 | 3/5 |
| 13 | Cutler and Gross S.r.l. Domegge di Cadore | Maker's own entity Authorised representative, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 4/5 |
| 14 | DI ESSE S.R.L. domegge di cadore | Maker's own entity Distributor, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 4/5 |
| 15 | L.G.R srl Roma | Maker's own entity Authorised representative, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 4/5 |
| 16 | Più Forty S.r.l. Prato | Maker's own entity Distributor, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 4/5 |
| 17 | ALEX OCCHIALI SRL Treviso (TV) | Maker's own entity Distributor, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 3/5 |
| 18 | PUMAK TRADING S.R.L. UDINE | Maker's own entity Distributor, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 3/5 |
| 19 | STAR LIGHT S.R.L. VALDOBBIADENE | Maker's own entity Distributor, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 3/5 |
| 20 | Vision Up and Logoservice S.r.l. Roma | Maker's own entity 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 148 establishments in Italy with ophthalmic in their registry record, of which 6 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), EUDAMED, MHRA UK and Health Canada 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 23 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 68 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- UK MHRA Public Access Registration Database (PARD): 26 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 4 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 2 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
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.