Updated 22 October 2026
Anaesthesia and respiratory device distributors in Italy: 32 licensed establishments
The Bastion Hale Distributor Index lists 32 establishments in Italy whose registry records include anaesthesia and respiratory: 24 with a channel role (importer, distributor, wholesaler or authorised representative), 3 registration holders without a channel role, and 5 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.
Anaesthesia and respiratory covers ventilators, anaesthesia machines, airway consumables, oxygen therapy and sleep devices. Capital equipment and consumables often travel through the same distributor, which makes service capability a buying factor. Home respiratory care adds a non-hospital channel in several markets.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 24 | 75% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 7 | 22% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 10 | 31% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 23 | 72% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 6 | 19% | 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 anaesthesia and respiratory 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 | QUANTA SYSTEM, S.P.A. Samarate, VA | Channel Importer, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Gastroenterology, urology and OB/GYN +1 more | 70 | 27 | 0 | 57.9 | 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 | 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 |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 |
| 9 | MEDESY srl maniago | Channel Importer, Manufacturer | Anaesthesia and respiratory, Dental, In-vitro diagnostics +2 more | 33 | 1 | 0 | 36.5 | 4/5 |
| 10 | 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 |
| 11 | EB NEURO, S.P.A. FIRENZE | Channel Importer, Manufacturer | Anaesthesia and respiratory, Cardiovascular, Patient monitoring and neurology | 8 | 2 | 0 | 31.6 | 4/5 |
| 12 | HMC PREMEDICAL S.P.A. Mirandola (MO) | Channel Importer, Authorised representative, Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Gastroenterology, urology and OB/GYN | 4 | 2 | 0 | 30.3 | 4/5 |
| 13 | Spencer Italia s.r.l. Sala Baganza - Parma | Channel Importer, Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Patient monitoring and neurology +1 more | 9 | 1 | 0 | 30.3 | 4/5 |
| 14 | Dima Italia S.r.l. Bologna | Channel Importer, Manufacturer | Anaesthesia and respiratory | 4 | 1 | 0 | 26.7 | 3/5 |
| 15 | INTERSURGICAL S.P.A. Mirandola | Channel Importer, Manufacturer | Anaesthesia and respiratory, Dental | 3 | 1 | 0 | 25.6 | 4/5 |
| 16 | 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 |
| 17 | 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 |
| 18 | M.T.V. MEDICAL S.R.L. Castiglione delle Stiviere | Channel Importer, Authorised representative | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 0 | 0 | 5 | 22.2 | 4/5 |
| 19 | PLAN 1 HEALTH S.r.l. AMARO (UD) | Channel Importer, Manufacturer | Anaesthesia and respiratory | 1 | 1 | 0 | 22.1 | 4/5 |
| 20 | AGISAN S.A.S. di Biagi Alberto & C. LIVORNO | Channel Importer | Anaesthesia and respiratory, General hospital and consumables | 0 | 0 | 5 | 19.9 | 4/5 |
Questions about anaesthesia and respiratory distributors in Italy
How many anaesthesia and respiratory distributors are there in Italy?
The Index counts 32 establishments in Italy with anaesthesia and respiratory in their registry record, of which 24 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 anaesthesia and respiratory 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 anaesthesia and respiratory 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 anaesthesia and respiratory 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 anaesthesia and respiratory 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
Anaesthesia and respiratory in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 28 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: 24 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 10 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.