Updated 22 October 2026
ENT device distributors in Italy: 25 licensed establishments
The Bastion Hale Distributor Index lists 25 establishments in Italy whose registry records include ear, nose and throat: 16 with a channel role (importer, distributor, wholesaler or authorised representative), 1 registration holders without a channel role, and 8 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.
Ear, nose and throat covers hearing devices, cochlear implants, sinus and laryngology instruments, and audiology equipment. Hearing aids often go through retail audiology chains rather than hospital distributors, so the establishment list mixes both. Volumes per establishment are smaller than in surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 16 | 64% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 1 | 4% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 4 | 16% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 8 | 32% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 20 | 80% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 5 | 20% | 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 ear, nose and throat 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 | COSMED S.R.L. Albano Laziale, RM | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 196 | 15 | 0 | 60.4 | 3/5 |
| 2 | Sorin Group Italia S.r.L. Milan, MO | Channel Importer, Authorised representative, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, Ear, nose and throat +2 more | 129 | 23 | 0 | 60.2 | 3/5 |
| 3 | MicroPort CRM S.r.l. Saluggia (VC), VC | Channel Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, Ear, nose and throat, Patient monitoring and neurology +1 more | 87 | 29 | 0 | 59.3 | 3/5 |
| 4 | 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 |
| 5 | Micerium S.p.A. Avegno, GE | Channel Importer, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +1 more | 48 | 7 | 0 | 48.9 | 4/5 |
| 6 | Air Liquide Medical Systems S.r.l. Milano, MI | Channel Importer, Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Ear, nose and throat | 24 | 24 | 0 | 48.4 | 4/5 |
| 7 | 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 |
| 8 | 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 |
| 9 | GILARDONI S.P.A. Milan, LC | Channel Importer, Registration holder, Manufacturer | Ear, nose and throat, Imaging, radiology and radiotherapy | 3 | 2 | 0 | 31.5 | 4/5 |
| 10 | FLAEM NUOVA S.P.A. San Martino della Battaglia - Desenzano del Garda (BS) | Channel Importer, Manufacturer | Ear, nose and throat, Patient monitoring and neurology | 2 | 1 | 0 | 24.2 | 4/5 |
| 11 | Ars Chirurgica S.r.l. San Giovanni in Persiceto | Channel Importer | Ear, nose and throat, Gastroenterology, urology and OB/GYN, Imaging, radiology and radiotherapy +1 more | 0 | 0 | 17 | 24.1 | 4/5 |
| 12 | M.T.V. MEDICAL S.R.L. Castiglione delle Stiviere | Channel Importer, Authorised representative | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 0 | 0 | 5 | 22.2 | 4/5 |
| 13 | AUDIO TECHNOLOGIES S.R.L. Gossolengo (PC) | Channel Importer, Manufacturer | Ear, nose and throat | 1 | 1 | 0 | 22.1 | 4/5 |
| 14 | DIGI MEDICA SRL NAPOLI | Channel Importer | Ear, nose and throat | 0 | 0 | 3 | 18.4 | 4/5 |
| 15 | Koo Europe S.r.l MILANO | Channel Importer, Authorised representative | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 0 | 0 | 1 | 18.0 | 4/5 |
| 16 | DIPO S.r.l. Roma | Channel Importer | Aesthetics, dermatology and lasers, General hospital and consumables, Ear, nose and throat +3 more | 0 | 0 | 1 | 15.7 | 4/5 |
| 17 | Mectron S.p.A. Carasco (GE), GE | Holder Registration holder, Manufacturer | Dental, Ear, nose and throat, Patient monitoring and neurology +2 more | 51 | 16 | 0 | 51.1 | 4/5 |
| 18 | STERIL VERONA s.r.l. ERBE Verona | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 176 | 3 | 0 | 42.4 | 3/5 |
| 19 | DEN. TAG S.R.L. Maniago | Manufacturer Manufacturer | General hospital and consumables, Dental, Ear, nose and throat +2 more | 64 | 1 | 0 | 37.5 | 4/5 |
| 20 | Spes Medica S.p.A. Genova | Manufacturer Manufacturer, Exporter | Ear, nose and throat, Gastroenterology, urology and OB/GYN, Patient monitoring and neurology +1 more | 16 | 2 | 0 | 34.9 | 4/5 |
Questions about ear, nose and throat distributors in Italy
How many ear, nose and throat distributors are there in Italy?
The Index counts 25 establishments in Italy with ear, nose and throat in their registry record, of which 16 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 ear, nose and throat 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 ear, nose and throat 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 ear, nose and throat 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 ear, nose and throat 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
Ear, nose and throat in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 22 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: 19 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 8 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
- web (public register): 5 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.