Updated 22 October 2026
Imaging and radiology equipment distributors in Italy: 44 licensed establishments
The Bastion Hale Distributor Index lists 44 establishments in Italy whose registry records include imaging, radiology and radiotherapy: 17 with a channel role (importer, distributor, wholesaler or authorised representative), 8 registration holders without a channel role, and 19 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.
Imaging, radiology and radiotherapy covers X-ray, ultrasound, CT, MRI, nuclear medicine and treatment systems. The Index lists these establishments because the registries contain them.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 15 | 34% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 5 | 11% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 15 | 34% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 38 | 86% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 4 | 9% | 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 imaging, radiology and radiotherapy 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 | Orthofix Srl Milano | Channel Importer, Authorised representative, Registration holder, Manufacturer, Exporter | Patient monitoring and neurology, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy +1 more | 110 | 17 | 0 | 59.1 | 4/5 |
| 2 | CEFLA s.c. Imola, BO | Channel Importer, Registration holder, Manufacturer | General hospital and consumables, Dental, Orthopaedics, spine and trauma +1 more | 100 | 28 | 0 | 58.6 | 4/5 |
| 3 | Esaote S.p.A. Genoa | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, Orthopaedics, spine and trauma +1 more | 93 | 18 | 0 | 57.5 | 3/5 |
| 4 | THD S.P.A. Correggio, RE | Channel Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, Imaging, radiology and radiotherapy +1 more | 57 | 12 | 0 | 53.2 | 3/5 |
| 5 | 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 |
| 6 | General Medical Merate S.p.A. Seriate, BG | Channel Authorised representative, Registration holder, Manufacturer | Patient monitoring and neurology, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 44 | 5 | 0 | 47.1 | 4/5 |
| 7 | Trident S.r.l. MILANO, BS | Channel Importer, Registration holder, Manufacturer | Dental, Imaging, radiology and radiotherapy | 7 | 3 | 0 | 36.4 | 4/5 |
| 8 | 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 |
| 9 | 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 |
| 10 | Biomedica Italia Srl Assago | Channel Importer | Anaesthesia and respiratory, General hospital and consumables, Patient monitoring and neurology +3 more | 0 | 0 | 22 | 25.0 | 4/5 |
| 11 | CERACARTA S.p.A. FORLI | Channel Importer, Manufacturer | Cardiovascular, Imaging, radiology and radiotherapy | 2 | 1 | 0 | 24.2 | 4/5 |
| 12 | Villa Sistemi Medicali S.p.A. Buccinasco | Channel Authorised representative, Manufacturer | Imaging, radiology and radiotherapy | 2 | 1 | 0 | 24.2 | 4/5 |
| 13 | 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 |
| 14 | Aurogene Srl Roma | Channel Importer | General hospital and consumables, In-vitro diagnostics, Imaging, radiology and radiotherapy | 0 | 0 | 16 | 23.9 | 4/5 |
| 15 | Metaltronica SpA Pomezia | Channel Importer, Authorised representative, Manufacturer | Imaging, radiology and radiotherapy | 1 | 1 | 0 | 23.7 | 4/5 |
| 16 | APTIVA MEDICAL S.R.L. Milano | Channel Importer | Cardiovascular, Gastroenterology, urology and OB/GYN, Patient monitoring and neurology +2 more | 0 | 0 | 14 | 23.4 | 4/5 |
| 17 | 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 |
| 18 | Zirkonzahn SRL Gais (BZ), BZ | Holder Registration holder, Manufacturer | Dental, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy +1 more | 1871 | 22 | 0 | 67.5 | 4/5 |
| 19 | de Götzen S.r.l. Fagnano Olona, VA | Holder Registration holder, Manufacturer, Exporter | Dental, Imaging, radiology and radiotherapy | 32 | 9 | 0 | 47.9 | 4/5 |
| 20 | CENTERVUE S.P.A. Padova | Holder Registration holder, Manufacturer | Ophthalmic, Imaging, radiology and radiotherapy | 10 | 11 | 0 | 41.6 | 4/5 |
Questions about imaging, radiology and radiotherapy distributors in Italy
How many imaging, radiology and radiotherapy distributors are there in Italy?
The Index counts 44 establishments in Italy with imaging, radiology and radiotherapy in their registry record, of which 17 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 imaging, radiology and radiotherapy 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 imaging, radiology and radiotherapy 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 imaging, radiology and radiotherapy 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 imaging, radiology and radiotherapy 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
Imaging, radiology and radiotherapy in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 39 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: 38 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 15 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
- web (public register): 6 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.