Updated 22 October 2026
Orthopaedic and spine device distributors in Italy: 57 licensed establishments
The Bastion Hale Distributor Index lists 57 establishments in Italy whose registry records include orthopaedics, spine and trauma: 25 with a channel role (importer, distributor, wholesaler or authorised representative), 6 registration holders without a channel role, and 26 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.
Orthopaedics covers implants for joints, spine and trauma, together with instruments and bone substitutes. Implants are usually Class IIb or III, so the importer or registration holder carries real regulatory work and hospitals often buy through tenders. Distributors in this segment tend to employ clinical support staff who attend surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 24 | 42% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 5 | 9% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 15 | 26% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 49 | 86% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 7 | 12% | 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 orthopaedics, spine and trauma 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 | 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 |
| 2 | 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 |
| 3 | 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 |
| 4 | 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 |
| 5 | LIMACORPORATE S.p.A. Villanova di San Daniele del Friuli, UD | Channel Importer, Registration holder, Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 204 | 9 | 0 | 57.2 | 4/5 |
| 6 | Corcym S.r.l. Milan, VC | Channel Importer, Authorised representative, Registration holder, Manufacturer | Cardiovascular, Orthopaedics, spine and trauma, Surgery and endoscopy | 34 | 23 | 0 | 53.6 | 3/5 |
| 7 | Tecres S.p.A. Sommacampagna, VR | Channel Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, Orthopaedics, spine and trauma, Surgery and endoscopy | 40 | 18 | 0 | 53.3 | 4/5 |
| 8 | 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 |
| 9 | Omnia S.r.l Fidenza, PR | Channel Importer, Registration holder, Manufacturer | Dental, Orthopaedics, spine and trauma, Surgery and endoscopy | 29 | 10 | 0 | 47.9 | 3/5 |
| 10 | 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 |
| 11 | MEDESY srl maniago | Channel Importer, Manufacturer | Anaesthesia and respiratory, Dental, In-vitro diagnostics +2 more | 33 | 1 | 0 | 36.5 | 4/5 |
| 12 | ADLER ORTHO S.P.A. Cormano | Channel Importer, Manufacturer | Orthopaedics, spine and trauma | 20 | 2 | 0 | 35.9 | 4/5 |
| 13 | BIOPSYBELL S.R.L. mirandola | Channel Importer, Manufacturer, Exporter | Anaesthesia and respiratory, Gastroenterology, urology and OB/GYN, Orthopaedics, spine and trauma +1 more | 15 | 1 | 0 | 34.2 | 4/5 |
| 14 | Citieffe s.r.l. Calderara di Reno | Channel Importer, Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 19 | 1 | 0 | 33.8 | 4/5 |
| 15 | Intrauma S.p.A. Bruino | Channel Importer, Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 8 | 1 | 0 | 29.7 | 4/5 |
| 16 | HUMAN BRAIN WAVE SRL Torino | Channel Importer, Manufacturer | In-vitro diagnostics, Orthopaedics, spine and trauma, Surgery and endoscopy | 5 | 1 | 0 | 27.7 | 4/5 |
| 17 | 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 |
| 18 | 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 |
| 19 | GRUPPO BIOIMPIANTI S.R.L. PESCHIERA BORROMEO (MI) | Channel Importer, Manufacturer | Orthopaedics, spine and trauma | 2 | 1 | 0 | 24.2 | 4/5 |
| 20 | 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 |
Questions about orthopaedics, spine and trauma distributors in Italy
How many orthopaedics, spine and trauma distributors are there in Italy?
The Index counts 57 establishments in Italy with orthopaedics, spine and trauma in their registry record, of which 25 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 orthopaedics, spine and trauma 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 orthopaedics, spine and trauma 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 orthopaedics, spine and trauma 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 orthopaedics, spine and trauma 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
Orthopaedics, spine and trauma in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 48 establishments, last seen 22 October 2026. US government work, public domain.
- 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.
- 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): 8 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.