Updated 23 October 2026
Orthopaedic and spine device distributors in Italy: 66 licensed establishments
Italy has 5 independent distributors in the Index so far.
The Bastion Hale Distributor Index lists 66 establishments in Italy whose registry records include orthopaedics, spine and trauma: 5 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 21 manufacturers' own import or sales entities, 0 regulatory representatives, and 40 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.
Listed
Independent distributors in the Index here, ranked by the lines each distributor carries, then registrations, then size.
- 1APTIVA MEDICAL S.R.L.Milano14 lines0 registrationssize 20.0
- 2ELSE Solutions S.r.l.Trezzano sul Naviglio2 lines0 registrationssize 16.1
- 3ADIM S.R.L.Giulianova0 lines0 registrationssize 9.7
- 4Chirurmedica srlPescara0 lines0 registrationssize 9.7
- 5CONECTO S.R.L.Mantova0 lines0 registrationssize 9.7
Include manufacturers, their own sales entities and regulatory representatives (61)
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.
- 1Biomedica Italia SrlAssago22 lines0 registrationssize 21.6
- 2Corios S.c.San Giuliano Milanese16 lines0 registrationssize 22.7
- 3ADLER ORTHO S.P.A.Cormano0 lines140 registrationssize 66.1
- 4LIMACORPORATE S.p.A.Villanova di San Daniele del Friuli, UD0 lines40 registrationssize 65.7
- 5MicroPort CRM S.r.l.Saluggia (VC), VC0 lines37 registrationssize 62.3
- 6CEFLA s.c.Imola, BO0 lines30 registrationssize 60.8
- 7Orthofix S.r.l.Milano0 lines28 registrationssize 63.2
- 8Tecres S.p.A.Sommacampagna, VR0 lines25 registrationssize 56.6
- 9Corcym S.r.l.Milan, VC0 lines24 registrationssize 55.6
- 10Esaote S.p.A.Genoa0 lines19 registrationssize 59.6
- 11Omnia S.r.lFidenza, PR0 lines12 registrationssize 50.5
- 12BIOPSYBELL S.R.L.mirandola, MO0 lines9 registrationssize 44.2
- 13General Medical Merate S.p.A.Seriate, BG0 lines7 registrationssize 50.3
- 14STERIS S.r.l.Segrate MI0 lines3 registrationssize 47.9
- 15Intrauma S.p.A.Bruino0 lines2 registrationssize 34.0
- 16MEDESY srlmaniago0 lines1 registrationsize 38.9
- 17Citieffe s.r.l.Calderara di Reno0 lines1 registrationsize 36.2
- 18HUMAN BRAIN WAVE SRLTorino0 lines1 registrationsize 30.1
- 19GRUPPO BIOIMPIANTI S.R.L.PESCHIERA BORROMEO (MI)0 lines1 registrationsize 24.2
- 20RO+TEN SRLMILAN0 lines0 registrationssize 11.9
See Germany: 880 independent distributors
Distributor in Italy? Add your company, free
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 | 25 | 38% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 1 | 2% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 6 | 9% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 15 | 23% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 56 | 85% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 7 | 11% | 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.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later. The Next 10 Markets report covers who holds the registration in each of your ten markets.
Questions about orthopaedics, spine and trauma distributors in Italy
How many orthopaedics, spine and trauma distributors are there in Italy?
The Index counts 66 establishments in Italy with orthopaedics, spine and trauma in their registry record, of which 5 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 23 October 2026.
Who can hold an 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 an 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 see the top three names. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as an 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: 50 establishments, last seen 23 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 46 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- UK MHRA Public Access Registration Database (PARD): 35 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 15 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 10 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.