Updated 22 October 2026
Cardiovascular device distributors in Italy: 34 licensed establishments
The Bastion Hale Distributor Index lists 34 establishments in Italy whose registry records include cardiovascular: 20 with a channel role (importer, distributor, wholesaler or authorised representative), 5 registration holders without a channel role, and 9 registered as manufacturer or exporter only, out of 3,680 medical device establishments in Italy overall. The records come from US FDA (openFDA), EUDAMED and Health Canada, last seen on 22 October 2026.
Cardiovascular covers stents, catheters, pacemakers, heart valves, ECG and vascular access. Most products are implantable or high risk, which concentrates the segment in fewer, better capitalised importers. Reimbursement rules shape who can sell here more than in any other segment.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 19 | 56% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 1 | 3% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 6 | 18% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 17 | 50% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 33 | 97% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 9 | 26% | 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 cardiovascular 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 | 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 | 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 |
| 6 | Spectrum Medical S.r.l. Mirandola, MO | Channel Importer, Authorised representative, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular | 27 | 19 | 0 | 52.6 | 3/5 |
| 7 | 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 |
| 8 | MIR - Medical International Research S.p.A. Rome, RM | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables | 29 | 10 | 0 | 47.9 | 4/5 |
| 9 | 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 |
| 10 | Instrumentation Laboratory SpA Milano | Channel Importer, Authorised representative, Manufacturer, Exporter | Cardiovascular, In-vitro diagnostics, Surgery and endoscopy | 117 | 2 | 0 | 47.5 | 4/5 |
| 11 | FIAB S.p.A. Vicchio, FI | Channel Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Patient monitoring and neurology +2 more | 18 | 9 | 0 | 46.4 | 4/5 |
| 12 | EUROSETS S.R.L. Medolla, MO | Channel Importer, Registration holder, Manufacturer | Cardiovascular | 9 | 7 | 0 | 40.8 | 4/5 |
| 13 | GEM Srl VIAREGGIO, LU | Channel Importer, Registration holder, Manufacturer | Cardiovascular, Surgery and endoscopy | 13 | 8 | 0 | 40.7 | 4/5 |
| 14 | Empatica S.r.L. Milan, MI | Channel Importer, Authorised representative, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +1 more | 11 | 3 | 0 | 39.7 | 4/5 |
| 15 | EB NEURO, S.P.A. FIRENZE | Channel Importer, Manufacturer | Anaesthesia and respiratory, Cardiovascular, Patient monitoring and neurology | 8 | 2 | 0 | 31.6 | 4/5 |
| 16 | Qualiteam s.r.l. Burolo | Channel Distributor, Manufacturer | Cardiovascular, General hospital and consumables, Patient monitoring and neurology | 9 | 1 | 0 | 30.3 | 4/5 |
| 17 | Cardioline S.P.A. TRENTO | Channel Importer, Authorised representative, Manufacturer | Cardiovascular | 2 | 1 | 0 | 25.8 | 4/5 |
| 18 | CERACARTA S.p.A. FORLI | Channel Importer, Manufacturer | Cardiovascular, Imaging, radiology and radiotherapy | 2 | 1 | 0 | 24.2 | 4/5 |
| 19 | MEDICAL INSTRUMENTS S.P.A. San Lazzaro di Savena | Channel Importer, Exporter | Cardiovascular, Surgery and endoscopy | 2 | 1 | 0 | 24.2 | 4/5 |
| 20 | BIOTEKNA S.R.L. MARCON (VE) | Channel Importer, Manufacturer | Cardiovascular, Patient monitoring and neurology | 2 | 1 | 0 | 24.2 | 3/5 |
Questions about cardiovascular distributors in Italy
How many cardiovascular distributors are there in Italy?
The Index counts 34 establishments in Italy with cardiovascular in their registry record, of which 20 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA), EUDAMED and Health Canada and was last refreshed on 22 October 2026.
Who can hold a cardiovascular 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 cardiovascular 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 shortlist with our read on each name, book the International Launch Audit.
What does the Distributor Index count as a cardiovascular 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 cardiovascular 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
Cardiovascular in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 32 establishments, last seen 22 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 27 establishments, last seen 22 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 17 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
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.