Updated 22 October 2026
Gastroenterology and urology device distributors in Italy: 75 licensed establishments
The Bastion Hale Distributor Index lists 75 establishments in Italy whose registry records include gastroenterology, urology and ob/gyn: 3 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 20 manufacturers' own import or sales entities, 0 regulatory representatives, and 52 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.
Gastroenterology, urology and obstetrics covers flexible endoscopy accessories, lithotripsy, dialysis, catheters and women's health devices. Dialysis consumables bring large recurring volumes and a few dominant players. The rest of the segment is spread across many mid-sized importers.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 21 | 28% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 1 | 1% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 7 | 9% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 13 | 17% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 72 | 96% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 13 | 17% | 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 3 independent gastroenterology, urology and ob/gyn distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Ars Chirurgica S.r.l. San Giovanni in Persiceto | Distributor Importer | Ear, nose and throat, Gastroenterology, urology and OB/GYN, Imaging, radiology and radiotherapy +1 more | 0 | 0 | 16 | 20.5 | 4/5 |
| 2 | APTIVA MEDICAL S.R.L. Milano | Distributor Importer | Cardiovascular, Gastroenterology, urology and OB/GYN, Patient monitoring and neurology +2 more | 0 | 0 | 14 | 20.0 | 4/5 |
| 3 | ELSE Solutions S.r.l. Trezzano sul Naviglio | Distributor Importer, Authorised representative | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 0 | 0 | 2 | 16.1 | 4/5 |
Include manufacturers, their own sales entities and regulatory representatives (72)
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.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | SENTINEL CH. S.p.A. Milano, Lombardia | Maker's own entity Importer, Registration holder, Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 128 | 103 | 0 | 67.7 | 4/5 |
| 2 | Sorin Group Italia S.r.L. Milan, MO | Maker's own entity Importer, Authorised representative, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, Ear, nose and throat +2 more | 129 | 47 | 0 | 65.4 | 3/5 |
| 3 | THD S.P.A. Correggio, RE | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, Imaging, radiology and radiotherapy +1 more | 57 | 30 | 0 | 59.2 | 3/5 |
| 4 | QUANTA SYSTEM, S.P.A. Samarate, VA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Gastroenterology, urology and OB/GYN +1 more | 70 | 28 | 0 | 59.9 | 3/5 |
| 5 | HMC PREMEDICAL S.P.A. Mirandola (MO) | Maker's own entity Importer, Authorised representative, Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Gastroenterology, urology and OB/GYN | 17 | 19 | 0 | 48.1 | 4/5 |
| 6 | DELTA MED S.P.A. viadana, MN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, Surgery and endoscopy | 21 | 11 | 0 | 49.8 | 3/5 |
| 7 | Fidia farmaceutici S.p.A. Abano Terme, PD | Maker's own entity Importer, Registration holder, Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +1 more | 9 | 10 | 0 | 44.2 | 4/5 |
| 8 | BIOPSYBELL S.R.L. mirandola, MO | Maker's own entity Importer, Manufacturer, Exporter | Anaesthesia and respiratory, Gastroenterology, urology and OB/GYN, Orthopaedics, spine and trauma +1 more | 15 | 9 | 0 | 44.2 | 4/5 |
| 9 | Gambro Dasco S.P.A. Medolla, MO | Maker's own entity Authorised representative, Registration holder, Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN | 23 | 8 | 0 | 45.8 | 4/5 |
| 10 | Medica S.p.A. Medolla | Maker's own entity Importer, Authorised representative, Manufacturer | Gastroenterology, urology and OB/GYN | 17 | 7 | 0 | 43.8 | 4/5 |
| 11 | Assut Europe S.P.A. Rome, L'AQUILA | Maker's own entity Importer, Authorised representative, Manufacturer | Gastroenterology, urology and OB/GYN, Surgery and endoscopy | 6 | 7 | 0 | 39.0 | 4/5 |
| 12 | CORMAN S.p.A. Lacchiarella, MI | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Gastroenterology, urology and OB/GYN | 7 | 4 | 0 | 40.6 | 3/5 |
| 13 | STERIS S.r.l. Segrate MI | Maker's own entity Importer, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 171 | 3 | 0 | 47.9 | 4/5 |
| 14 | CEDIC S.R.L. Peschiera Borromeo, Milan | Maker's own entity Importer, Authorised representative, Registration holder, Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN | 7 | 3 | 0 | 39.5 | 4/5 |
| 15 | H.S. Hospital Service S.p.A. Roma | Maker's own entity Importer, Manufacturer | Gastroenterology, urology and OB/GYN, Surgery and endoscopy | 14 | 2 | 0 | 36.6 | 4/5 |
| 16 | STERIS Italy S.r.l. Pomezia | Maker's own entity Importer, Manufacturer | Gastroenterology, urology and OB/GYN, Patient monitoring and neurology, Surgery and endoscopy | 7 | 2 | 0 | 33.5 | 4/5 |
| 17 | MEDITALIA S.R.L.. PALERMO (PA) | Maker's own entity Importer, Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 5 | 2 | 0 | 32.0 | 4/5 |
| 18 | Sapi Med S.p.A. Alessandria | Maker's own entity Importer, Manufacturer | Gastroenterology, urology and OB/GYN | 7 | 1 | 0 | 31.5 | 4/5 |
| 19 | PENTAFERTE ITALIA S.R.L. Campli, TE | Maker's own entity Importer, Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN | 4 | 1 | 0 | 29.2 | 3/5 |
| 20 | DRYLOCK TECHNOLOGIES S.R.L. Buccinasco Milano | Maker's own entity Distributor, Manufacturer | Gastroenterology, urology and OB/GYN | 3 | 1 | 0 | 22.2 | 3/5 |
Questions about gastroenterology, urology and ob/gyn distributors in Italy
How many gastroenterology, urology and ob/gyn distributors are there in Italy?
The Index counts 75 establishments in Italy with gastroenterology, urology and ob/gyn in their registry record, of which 3 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 22 October 2026.
Who can hold a gastroenterology, urology and ob/gyn 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 gastroenterology, urology and ob/gyn 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 gastroenterology, urology and ob/gyn 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 gastroenterology, urology and ob/gyn 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
Gastroenterology, urology and OB/GYN in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 71 establishments, last seen 23 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 54 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- UK MHRA Public Access Registration Database (PARD): 36 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 13 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 3 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
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.