Updated 22 October 2026
Surgical and endoscopy device distributors in Italy: 115 licensed establishments
The Bastion Hale Distributor Index lists 115 establishments in Italy whose registry records include surgery and endoscopy: 6 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 41 manufacturers' own import or sales entities, 0 regulatory representatives, and 68 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.
General and plastic surgery covers instruments, electrosurgery, endoscopes, sutures and staplers. Most registries place surgical instruments in their largest category, so this segment usually has the most establishments and the widest spread of company sizes. Many of them are small instrument makers and importers rather than full-line distributors.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 46 | 40% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 2 | 2% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 8 | 7% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 26 | 23% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 107 | 93% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 18 | 16% | 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 surgery and endoscopy 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 | Ars Chirurgica S.r.l. San Giovanni in Persiceto | Distributor Importer | Ear, nose and throat, Gastroenterology, urology and OB/GYN, Imaging, radiology and radiotherapy +1 more | 0 | 0 | 16 | 20.5 | 4/5 |
| 2 | MEDICAL INSTRUMENTS S.P.A. San Lazzaro di Savena | Distributor Importer, Exporter | Cardiovascular, Surgery and endoscopy | 2 | 1 | 10 | 33.3 | 5/5 |
| 3 | ELSE Solutions S.r.l. Trezzano sul Naviglio | Distributor Importer, Authorised representative | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 0 | 0 | 2 | 16.1 | 4/5 |
| 4 | Chiru-med Pescara | Distributor Importer | Surgery and endoscopy | 0 | 0 | 0 | 9.7 | 3/5 |
| 5 | Chirurmedica srl Pescara | Distributor Importer | Cardiovascular, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 0 | 0 | 0 | 9.7 | 3/5 |
| 6 | CONECTO S.R.L. Mantova | Distributor Importer | Patient monitoring and neurology, Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 0 | 9.7 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (109)
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 | Biomedica Italia Srl Assago | Maker's own entity Importer | Anaesthesia and respiratory, General hospital and consumables, Patient monitoring and neurology +3 more | 0 | 0 | 22 | 21.6 | 4/5 |
| 2 | Sorin Group Italia S.r.L. Milan, MO | Maker's own entity Importer, Authorised representative, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, Ear, nose and throat +2 more | 129 | 47 | 0 | 65.4 | 3/5 |
| 3 | LIMACORPORATE S.p.A. Villanova di San Daniele del Friuli, UD | Maker's own entity Importer, Registration holder, Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 204 | 40 | 0 | 65.7 | 4/5 |
| 4 | DEKA M.E.L.A. S.R.L. Calenzano (FI), FI | Maker's own entity Importer, Registration holder, Manufacturer | Dental, Surgery and endoscopy | 119 | 30 | 0 | 59.8 | 4/5 |
| 5 | THD S.P.A. Correggio, RE | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, Imaging, radiology and radiotherapy +1 more | 57 | 30 | 0 | 59.2 | 3/5 |
| 6 | Orthofix S.r.l. Milano | Maker's own entity Importer, Authorised representative, Registration holder, Manufacturer, Exporter | Patient monitoring and neurology, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy +1 more | 110 | 28 | 0 | 63.2 | 4/5 |
| 7 | QUANTA SYSTEM, S.P.A. Samarate, VA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Gastroenterology, urology and OB/GYN +1 more | 70 | 28 | 0 | 59.9 | 3/5 |
| 8 | Tecres S.p.A. Sommacampagna, VR | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, Orthopaedics, spine and trauma, Surgery and endoscopy | 40 | 25 | 0 | 56.6 | 4/5 |
| 9 | Corcym S.r.l. Milan, VC | Maker's own entity Importer, Authorised representative, Registration holder, Manufacturer | Cardiovascular, Orthopaedics, spine and trauma, Surgery and endoscopy | 34 | 24 | 0 | 55.6 | 3/5 |
| 10 | INVENTIS S.r.l. Padova | Maker's own entity Importer, Registration holder, Manufacturer | General hospital and consumables, Ear, nose and throat, In-vitro diagnostics +2 more | 35 | 19 | 0 | 53.5 | 4/5 |
| 11 | 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 |
| 12 | GEM S.r.l VIAREGGIO, LU | Maker's own entity Importer, Registration holder, Manufacturer | Cardiovascular, Surgery and endoscopy | 13 | 13 | 0 | 45.2 | 4/5 |
| 13 | Omnia S.r.l Fidenza, PR | Maker's own entity Importer, Registration holder, Manufacturer | Dental, Orthopaedics, spine and trauma, Surgery and endoscopy | 29 | 12 | 0 | 50.5 | 3/5 |
| 14 | DELTA MED S.P.A. viadana, MN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, Surgery and endoscopy | 21 | 11 | 0 | 49.8 | 3/5 |
| 15 | Fidia farmaceutici S.p.A. Abano Terme, PD | Maker's own entity Importer, Registration holder, Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +1 more | 9 | 10 | 0 | 44.2 | 4/5 |
| 16 | BIOPSYBELL S.R.L. mirandola, MO | Maker's own entity Importer, Manufacturer, Exporter | Anaesthesia and respiratory, Gastroenterology, urology and OB/GYN, Orthopaedics, spine and trauma +1 more | 15 | 9 | 0 | 44.2 | 4/5 |
| 17 | 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 |
| 18 | Assut Europe S.P.A. Rome, L'AQUILA | Maker's own entity Importer, Authorised representative, Manufacturer | Gastroenterology, urology and OB/GYN, Surgery and endoscopy | 6 | 7 | 0 | 39.0 | 4/5 |
| 19 | BIOS S.R.L. Vimodrone, MI | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Patient monitoring and neurology, Surgery and endoscopy | 21 | 5 | 0 | 46.6 | 4/5 |
| 20 | BIOTEC S.R.L. Povolaro di Dueville, Vicenza | Maker's own entity Importer, Manufacturer | Surgery and endoscopy | 4 | 5 | 0 | 34.3 | 3/5 |
Questions about surgery and endoscopy distributors in Italy
How many surgery and endoscopy distributors are there in Italy?
The Index counts 115 establishments in Italy with surgery and endoscopy 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 surgery and endoscopy 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 surgery and endoscopy 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 surgery and endoscopy 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 surgery and endoscopy 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
Surgery and endoscopy in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 103 establishments, last seen 23 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 95 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- UK MHRA Public Access Registration Database (PARD): 71 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 26 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 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.