Updated 22 October 2026
Medical device distributors in Ecuador: 3 licensed establishments
The Bastion Hale Distributor Index lists 3 medical device establishments registered with an address in Ecuador: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 0 manufacturers' own import or sales entities, 0 regulatory representatives (authorised representatives or registration holders with no import or distribution role), and 3 manufacturers or exporters. The records come from US FDA (openFDA), last seen on 22 October 2026.
By segment
| Segment | Establishments | |
|---|---|---|
| Surgery and endoscopy | 2 | Search in the Index |
| Orthopaedics, spine and trauma | 1 | Search in the Index |
| Ear, nose and throat | 1 | Search in the Index |
| Gastroenterology, urology and OB/GYN | 3 | Search in the Index |
| Dental | 1 | Search in the Index |
| In-vitro diagnostics | 1 | Search in the Index |
| General hospital and consumables | 2 | Search in the Index |
| Imaging, radiology and radiotherapy | 2 | Search in the Index |
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.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Manufacturer | 1 | 33% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 2 | 67% | 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 Ecuador
Who holds the registration varies by market and often sits with the local importer. Check the national rule before signing a distributor; the Next 10 Markets report covers it for your target markets.
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 it per market.
Top 0 independent distributors
Independent distributors only: a channel role (importer, distributor, wholesaler, authorised representative), no manufacturing of their own and no sign of being a manufacturer's own sales company. Ranked by the other manufacturers' lines they carry, then registrations held, then size (a 0 to 100 score). Complete is 0 to 5 for website, address, segments, principals and counts.
No independent distributor is registered here yet; every establishment on record is a manufacturer or a manufacturer's own sales entity.
Include manufacturers, their own sales entities and regulatory representatives (3)
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 | ALEM Quito Pichincha | Manufacturer Exporter | General hospital and consumables, Ear, nose and throat, Gastroenterology, urology and OB/GYN +2 more | 100 | 1 | 0 | 36.3 | 3/5 |
| 2 | BIOCELLS DISCOVERIES INTERNACIONAL (BIOCELLS) Quito Pichincha | Manufacturer Exporter | General hospital and consumables, Dental, Gastroenterology, urology and OB/GYN +4 more | 78 | 1 | 0 | 35.1 | 3/5 |
| 3 | ZAIMELLA DEL ECUADOR S A QUITO Pichincha | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN | 1 | 1 | 0 | 16.5 | 3/5 |
Questions about medical device distributors in Ecuador
How many medical device distributors are there in Ecuador?
The Index counts 3 medical device establishments registered in Ecuador, of which 0 are independent distributors: importers, distributors, wholesalers or authorised representatives that do not manufacture themselves and are not a manufacturer's own sales company. The rest are manufacturers or their own sales entities. The number comes from US FDA (openFDA) and was last refreshed on 22 October 2026.
Who can hold a medical device registration in Ecuador?
Who holds the registration varies by market and often sits with the local importer. Check the national rule before signing a distributor; the Next 10 Markets report covers it for your target markets.
How do I find a medical device distributor in Ecuador?
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 Ecuador to see the counts for your segment and reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a distributor in Ecuador?
An establishment is a company that appears in a public regulatory registry with an address in Ecuador, 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.
Related markets in Latin America and the Caribbean
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 3 establishments, last seen 22 October 2026. US government work, public domain.
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.