Updated 22 October 2026
Medical device distributors in Guatemala: 5 licensed establishments
The Bastion Hale Distributor Index lists 5 medical device establishments registered with an address in Guatemala: 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 5 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 | 2 | Search in the Index |
| Cardiovascular | 2 | Search in the Index |
| Gastroenterology, urology and OB/GYN | 3 | Search in the Index |
| Dental | 3 | Search in the Index |
| Anaesthesia and respiratory | 2 | Search in the Index |
| Patient monitoring and neurology | 2 | Search in the Index |
| In-vitro diagnostics | 2 | Search in the Index |
| General hospital and consumables | 3 | 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 | 5 | 100% | Registered as a manufacturer with an address in this market, including foreign registrations. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Guatemala
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 (5)
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 | Guatemala Medical Manufacturing Villa Canales Guatemala | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 70 | 1 | 0 | 34.5 | 3/5 |
| 2 | Ortho and Surgical Products Enterprises S.A. Villa Canales Guatemala | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 70 | 1 | 0 | 34.5 | 3/5 |
| 3 | ABSORTEX, S.A San Jose Pinula Guatemala | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN | 2 | 1 | 0 | 18.5 | 3/5 |
| 4 | INNOVACYCLE GUATEMALA S.A. MIXCO Guatemala | Manufacturer Manufacturer | General hospital and consumables | 2 | 1 | 0 | 18.5 | 3/5 |
| 5 | Colgate-Palmolive (C.A.) S.A. Zona 12 Guatemala | Manufacturer Manufacturer | Dental | 1 | 1 | 0 | 16.5 | 3/5 |
Questions about medical device distributors in Guatemala
How many medical device distributors are there in Guatemala?
The Index counts 5 medical device establishments registered in Guatemala, 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 Guatemala?
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 Guatemala?
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 Guatemala 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 Guatemala?
An establishment is a company that appears in a public regulatory registry with an address in Guatemala, 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: 5 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.