Updated 22 October 2026

Medical device distributors in Italy: 3,680 licensed establishments

The Bastion Hale Distributor Index lists 3,680 medical device establishments registered with an address in Italy: 1,253 with a channel role (importer, distributor, wholesaler or authorised representative), 38 registration holders without a channel role, and 2,389 registered as manufacturer or exporter only. The records come from EUDAMED, US FDA (openFDA) and Health Canada, last seen on 22 October 2026.

3,680establishments

1,253with a channel role

38registration holders

2,389manufacturers only

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By segment

Segment	Establishments
Surgery and endoscopy	106	Search in the Index
Orthopaedics, spine and trauma	49	Search in the Index
Cardiovascular	34	Search in the Index
Ear, nose and throat	20	Search in the Index
Gastroenterology, urology and OB/GYN	72	Search in the Index
Dental	68	Search in the Index
Anaesthesia and respiratory	24	Search in the Index
Patient monitoring and neurology	66	Search in the Index
Ophthalmic	143	Search in the Index
In-vitro diagnostics	49	Search in the Index
General hospital and consumables	90	Search in the Index
Aesthetics, dermatology and lasers	14	Search in the Index
Imaging, radiology and radiotherapy	38	Search in the Index
No segment in the registry record	3,186

Segments come from the device listings linked to each establishment, so one company can appear in several rows. Imaging and radiology are shown because the registries contain them; Bastion Hale's launch services do not cover them.

By role

Role	Establishments	Share	What it means
Importer	1,066	29%	Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence.
Distributor	24	1%	Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH).
Authorised representative	256	7%	Represents a foreign manufacturer towards the regulator (EU authorised representative and similar).
Registration holder	82	2%	Holds device licences or registrations in its own name (Health Canada MDALL licence holder).
Manufacturer	2,920	79%	Registered as a manufacturer with an address in this market, including foreign registrations.
Exporter	101	3%	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 Audit covers it per market.

Top 20 establishments by size

Channel roles (importer, distributor, wholesaler, authorised representative) are listed first, then registration holders, then manufacturers. Size is a 0 to 100 score built from products listed, registrations held, roles, sources and principals represented. Complete is 0 to 5 for website, address, segments, principals and counts.

#	Establishment	Roles	Segments	Products	Registrations	Size	Complete
1	SENTINEL CH. S.p.A. Milano	Channel Importer, Registration holder, Manufacturer	Gastroenterology, urology and OB/GYN, In-vitro diagnostics	128	67	63.9	4/5
2	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	60.4	3/5
3	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	60.2	3/5
4	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	59.3	3/5
5	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	59.1	4/5
6	CEFLA s.c. Imola, BO	Channel Importer, Registration holder, Manufacturer	General hospital and consumables, Dental, Orthopaedics, spine and trauma +1 more	100	28	58.6	4/5
7	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	57.9	3/5
8	Esaote S.p.A. Genoa	Channel Importer, Registration holder, Manufacturer, Exporter	Anaesthesia and respiratory, Cardiovascular, Orthopaedics, spine and trauma +1 more	93	18	57.5	3/5
9	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	57.2	4/5
10	Liofilchem S.r.l. Roseto Degli Abruzzi, TE	Channel Authorised representative, Registration holder, Manufacturer	In-vitro diagnostics	288	5	56.5	4/5
11	Kerr Italia, S.r.l. Scafati (SA), SA	Channel Importer, Authorised representative, Registration holder, Manufacturer	General hospital and consumables, Dental	74	17	56.1	3/5
12	DEKA M.E.L.A. S.R.L. Calenzano (FI), FI	Channel Importer, Registration holder, Manufacturer	Dental, Surgery and endoscopy	119	19	55.3	4/5
13	Corcym S.r.l. Milan, VC	Channel Importer, Authorised representative, Registration holder, Manufacturer	Cardiovascular, Orthopaedics, spine and trauma, Surgery and endoscopy	34	23	53.6	3/5
14	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	53.3	4/5
15	THD S.P.A. Correggio, RE	Channel Importer, Registration holder, Manufacturer, Exporter	General hospital and consumables, Gastroenterology, urology and OB/GYN, Imaging, radiology and radiotherapy +1 more	57	12	53.2	3/5
16	Spectrum Medical S.r.l. Mirandola, MO	Channel Importer, Authorised representative, Registration holder, Manufacturer, Exporter	Anaesthesia and respiratory, Cardiovascular	27	19	52.6	3/5
17	INVENTIS S.r.l. Padova	Channel Importer, Registration holder, Manufacturer	General hospital and consumables, Ear, nose and throat, In-vitro diagnostics +2 more	35	15	50.6	4/5
18	Micerium S.p.A. Avegno, GE	Channel Importer, Registration holder, Manufacturer	Aesthetics, dermatology and lasers, General hospital and consumables, Dental +1 more	48	7	48.9	4/5
19	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	48.4	4/5
20	MIR - Medical International Research S.p.A. Rome, RM	Channel Importer, Registration holder, Manufacturer	Anaesthesia and respiratory, Cardiovascular, General hospital and consumables	29	10	47.9	4/5

Questions about medical device distributors in Italy

How many medical device distributors are there in Italy?

The Index counts 3,680 medical device establishments registered in Italy, of which 1,253 hold a channel role as importer, distributor, wholesaler or authorised representative. The rest are registration holders or manufacturers. The number comes from EUDAMED, US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.

Who can hold a medical device registration in Italy?

How do I find a medical device distributor in Italy?

Start with the segment table on this page, open the top establishments and check their roles, principals and registration counts. Then search the Index for your device and Italy to see the counts for your segment and 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 distributor in Italy?

An establishment is a company that appears in a public regulatory registry with an address in Italy, in any of the roles importer, distributor, wholesaler, authorised representative, sponsor, registration holder, manufacturer or exporter. Each company is counted once per country even if it holds several licences or appears in several registries. No contacts or named individuals are collected.

Segment pages for Italy

Ophthalmic 143 Surgery and endoscopy 106 General hospital and consumables 90 Gastroenterology, urology and OB/GYN 72 Dental 68 Patient monitoring and neurology 66 Orthopaedics, spine and trauma 49 In-vitro diagnostics 49 Imaging, radiology and radiotherapy 38 Cardiovascular 34 Anaesthesia and respiratory 24 Ear, nose and throat 20 Aesthetics, dermatology and lasers 14

Related markets in EU and EEA

Germany 5,416 France 2,670 Netherlands 2,044 Spain 1,855 Poland 1,583 Sweden 927 Romania 872 Czechia 861 Belgium 690 Hungary 636

All markets

Sources

EUDAMED economic operator registration, European Commission public API: 3,522 establishments, last seen 22 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
US FDA Establishment Registration and Device Listing, openFDA bulk download: 489 establishments, last seen 22 October 2026. US government work, public domain.
Health Canada MDALL active licence listing and MDEL establishment licence listing: 84 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.