Updated 22 October 2026
In-vitro diagnostics distributors in Brazil: 12 licensed establishments
The Bastion Hale Distributor Index lists 12 establishments in Brazil whose registry records include in-vitro diagnostics: 0 with a channel role (importer, distributor, wholesaler or authorised representative), 0 registration holders without a channel role, and 12 registered as manufacturer or exporter only, out of 112 medical device establishments in Brazil overall. The records come from US FDA (openFDA), last seen on 22 October 2026.
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Manufacturer | 11 | 92% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 1 | 8% | 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 Brazil
In Brazil the ANVISA registration is held by a Brazilian Registration Holder (BRH). If the distributor is the BRH, it owns the registration; an independent holder lets you appoint and replace distributors under it.
Top 12 in-vitro diagnostics 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 | Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda Sao Paulo | Manufacturer Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +3 more | 119 | 1 | 0 | 37.2 | 3/5 |
| 2 | COMPANHIA BRASILEIRA DE ESTERILIZACAO Jarinu Sao Paulo | Manufacturer Manufacturer | General hospital and consumables, In-vitro diagnostics, Patient monitoring and neurology | 24 | 1 | 0 | 29.2 | 3/5 |
| 3 | Philips Medical Systems Ltda Varginha Minas Gerais | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 23 | 1 | 0 | 29.0 | 3/5 |
| 4 | GREINER BIO ONE BRASIL PRODUTOS MEDICOS HOSPITALAR AMERICANA Sao Paulo | Manufacturer Manufacturer | General hospital and consumables, In-vitro diagnostics | 19 | 1 | 0 | 28.1 | 3/5 |
| 5 | Kolplast Ci Ltda Itupeva Sao Paulo | Manufacturer Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +1 more | 12 | 1 | 0 | 25.9 | 3/5 |
| 6 | bioBoaVista Valinhos Sao Paulo | Manufacturer Manufacturer | General hospital and consumables, In-vitro diagnostics | 8 | 1 | 0 | 24.1 | 3/5 |
| 7 | MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDA Estrela Rio Grande do Sul | Manufacturer Manufacturer | In-vitro diagnostics, Patient monitoring and neurology, Surgery and endoscopy | 4 | 1 | 0 | 21.1 | 3/5 |
| 8 | ALACER INDUSTRIA ELETRONICA LTDA Sao Paulo | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 3 | 1 | 0 | 20.0 | 3/5 |
| 9 | SYSMEX DO BRASIL IND E COM LTDA Sao Jose dos Pinhais Parana | Manufacturer Manufacturer | In-vitro diagnostics | 2 | 1 | 0 | 18.5 | 3/5 |
| 10 | Trinity Biotech do Brasil Extrema Minas Gerais | Manufacturer Manufacturer | In-vitro diagnostics | 2 | 1 | 0 | 18.5 | 3/5 |
| 11 | BIOTECNO INDUSTRIA E COMERCIO LTDA SANTA ROSA Rio Grande do Sul | Manufacturer Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 16.5 | 3/5 |
| 12 | INDREL SCIENTIFIC LONDRINA Parana | Manufacturer Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 16.5 | 3/5 |
Questions about in-vitro diagnostics distributors in Brazil
How many in-vitro diagnostics distributors are there in Brazil?
The Index counts 12 establishments in Brazil with in-vitro diagnostics in their registry record, of which 0 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA) and was last refreshed on 22 October 2026.
Who can hold a in-vitro diagnostics device registration in Brazil?
In Brazil the ANVISA registration is held by a Brazilian Registration Holder (BRH). If the distributor is the BRH, it owns the registration; an independent holder lets you appoint and replace distributors under it.
How do I find a in-vitro diagnostics distributor in Brazil?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Brazil 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 in-vitro diagnostics distributor in Brazil?
A company that appears in a public regulatory registry with an address in Brazil and whose linked device listings fall in the in-vitro diagnostics segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Brazil
In-vitro diagnostics in other Latin America and the Caribbean markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 12 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.