Updated 22 October 2026
In-vitro diagnostics distributors in Brazil: 747 licensed establishments
The Bastion Hale Distributor Index lists 747 establishments in Brazil whose registry records include in-vitro diagnostics: 300 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 409 manufacturers' own import or sales entities, 11 regulatory representatives, and 27 manufacturers or exporters, out of 4,256 medical device establishments in Brazil overall. The records come from ANVISA Brazil, US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 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 |
|---|---|---|---|
| Importer | 665 | 89% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 680 | 91% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 739 | 99% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 321 | 43% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 319 | 43% | 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 20 independent in-vitro diagnostics 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 | PASSROD IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS PARA SAÚDE LTDA - ME Ribeirão Preto, SP | Distributor Importer, Distributor, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +10 more | 1017 | 855 | 150 | 89.8 | 5/5 |
| 2 | VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA São Paulo, SP | Distributor Importer, Registration holder | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +9 more | 3340 | 2387 | 150 | 86.9 | 4/5 |
| 3 | DESCARPACK DESCARTAVEIS DO BRASIL LTDA São Paulo, SP | Distributor Importer, Distributor, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 295 | 273 | 95 | 84.6 | 4/5 |
| 4 | MANDALA BRASIL IMPORTACAO E DISTRIBUICAO DE PRODUTO MEDICO HOSPITALAR LTDA Maringá, PR | Distributor Importer, Distributor, Registration holder, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +10 more | 518 | 402 | 72 | 86.5 | 5/5 |
| 5 | MONTSERRAT COMERCIAL IMPORTADORA E EXPORTADORA LTDA São Bernardo Do Campo, SP | Distributor Importer, Distributor, Registration holder, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 161 | 161 | 70 | 79.5 | 4/5 |
| 6 | ARGOSLAB DISTRIBUIDORA DE PRODUTOS PARA LABORATÓRIOS LTDA São Paulo, SP | Distributor Importer, Distributor, Registration holder | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +3 more | 679 | 633 | 84 | 86.6 | 5/5 |
| 7 | INJEX INDÚSTRIAS CIRÚRGICAS LTDA Ourinhos, SP | Distributor Importer, Distributor, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +3 more | 168 | 161 | 61 | 80.8 | 5/5 |
| 8 | MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA Vargem Grande Paulista, SP | Distributor Importer, Distributor, Registration holder, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +10 more | 536 | 423 | 66 | 86.6 | 4/5 |
| 9 | PURE LATAM BRAZIL COMERCIO DE PRODUTOS HOSPITALARES LTDA São Paulo, SP | Distributor Importer, Distributor, Registration holder | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +9 more | 161 | 152 | 42 | 77.4 | 4/5 |
| 10 | FIRSTLAB INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS PARA LABORATORIOS LTDA Pinhais, PR | Distributor Importer, Distributor, Registration holder, Manufacturer, Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +1 more | 110 | 104 | 44 | 76.1 | 4/5 |
| 11 | MEDMAX COMÉRCIO DE EQUIPAMENTOS MÉDICOS E SIMILARES LTDA- ME Santa Rita Do Sapucaí, MG | Distributor Importer, Distributor, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +4 more | 194 | 191 | 46 | 81.0 | 5/5 |
| 12 | INCOTERM SOLUÇÕES EM MEDIÇÃO LTDA Porto Alegre, RS | Distributor Importer, Distributor, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 81 | 78 | 38 | 72.7 | 5/5 |
| 13 | WILCOS DO BRASIL INDÚSTRIA E COMÉRCIO LTDA Petrópolis, RJ | Distributor Importer, Distributor, Registration holder, Manufacturer | General hospital and consumables, Dental, In-vitro diagnostics +3 more | 135 | 134 | 36 | 76.6 | 5/5 |
| 14 | CIENLABOR INDUSTRIA E COMERCIO LTDA João Pessoa, PB | Distributor Importer, Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 280 | 264 | 37 | 83.2 | 5/5 |
| 15 | H STRATTNER E CIA LTDA Rio De Janeiro, RJ | Distributor Importer, Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Cardiovascular, General hospital and consumables +8 more | 183 | 171 | 36 | 80.3 | 5/5 |
| 16 | CONTROLLER COMÉRCIO E SERVIÇOS LTDA Biguaçu, SC | Distributor Importer, Distributor, Registration holder | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, General hospital and consumables +5 more | 87 | 77 | 34 | 70.3 | 5/5 |
| 17 | VYTTRA DIAGNOSTICOS S.A. São Paulo, SP | Distributor Importer, Distributor, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +3 more | 647 | 636 | 44 | 88.1 | 5/5 |
| 18 | CMS PRODUTOS HOSPITALARES LTDA Aparecida De Goiânia, GO | Distributor Importer, Distributor, Registration holder, Exporter | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +5 more | 203 | 121 | 33 | 77.8 | 5/5 |
| 19 | ADAPT PRODUTOS OFTALMOLÓGICOS LTDA Barueri, SP | Distributor Importer, Distributor, Registration holder, Exporter | Aesthetics, dermatology and lasers, General hospital and consumables, In-vitro diagnostics +4 more | 63 | 53 | 34 | 68.2 | 5/5 |
| 20 | Enzytec Biotecnologia Ltda. Belo Horizonte, MG | Distributor Importer, Distributor, Registration holder | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 595 | 470 | 31 | 84.1 | 5/5 |
Include manufacturers, their own sales entities and regulatory representatives (445)
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 | MEDIX BRASIL LTDA Cascavel, PR | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 387 | 373 | 111 | 85.0 | 4/5 |
| 2 | NUTRIEX IMPORTACAO E EXPORTACAO DE PRODUTOS NUTRICIONAIS E FARMOQUIMICOS LTDA Aparecida De Goiânia, GO | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +7 more | 286 | 248 | 86 | 84.5 | 4/5 |
| 3 | LABOR IMPORT COMERCIAL IMPORTADORA E EXPORTADORA LTDA Osasco, SP | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +7 more | 230 | 219 | 91 | 83.4 | 5/5 |
| 4 | AUTO SUTURE DO BRASIL LTDA. São Paulo, SP | Maker's own entity Importer, Distributor, Registration holder, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 1529 | 965 | 101 | 89.8 | 4/5 |
| 5 | BIOMÉDICA EQUIPAMENTOS E SUPRIMENTOS HOSPITALARES LTDA Brasília, DF | Maker's own entity Importer, Distributor, Registration holder, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +7 more | 356 | 299 | 80 | 84.6 | 4/5 |
| 6 | CRAL ARTIGOS PARA LABORATORIO LTDA Cotia, SP | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | General hospital and consumables, Ear, nose and throat, In-vitro diagnostics +1 more | 240 | 240 | 70 | 83.6 | 5/5 |
| 7 | GRUPO MULTILASER S.A. São Paulo, SP | Maker's own entity Importer, Distributor, Registration holder | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 138 | 137 | 69 | 76.8 | 4/5 |
| 8 | JOHNSON & JOHNSON DO BRASIL INDUSTRIA E COMERCIO DE PRODUTOS PARA SAUDE LTDA Guarulhos Sao Paulo, SP | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Cardiovascular, General hospital and consumables +6 more | 1167 | 589 | 82 | 94.2 | 5/5 |
| 9 | HTS - TECNOLOGIA EM SAÚDE, COMÉRCIO, IMPORTAÇÃO E EXPORTAÇÃO LTDA Lagoa Santa, MG | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +6 more | 236 | 222 | 61 | 83.5 | 5/5 |
| 10 | CEI COMÉRCIO EXPORTAÇÃO E IMPORTAÇÃO DE MATERIAIS MÉDICOS LTDA Anápolis, GO | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 350 | 293 | 60 | 85.5 | 4/5 |
| 11 | CML- Centro Médico Logístico Ltda São Paulo, SP | Maker's own entity Importer, Distributor, Registration holder, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 187 | 165 | 50 | 80.4 | 5/5 |
| 12 | LABORATORIOS B. BRAUN S/A São Gonçalo, RJ | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 693 | 522 | 54 | 88.9 | 5/5 |
| 13 | ACCUMED PRODUTOS MÉDICO HOSPITALARES LTDA Duque De Caxias, RJ | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +3 more | 97 | 83 | 41 | 73.2 | 4/5 |
| 14 | DIAGNÓSTICA INDÚSTRIA E COMÉRCIO LTDA - ME Belo Horizonte, MG | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +3 more | 245 | 196 | 43 | 82.0 | 5/5 |
| 15 | ZIMMER BIOMET BRASIL LTDA São Paulo, SP | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +3 more | 660 | 342 | 56 | 87.7 | 5/5 |
| 16 | GE HEALTHCARE DO BRASIL COMERCIO E SERVICOS PARA EQUIPAMENTOS MEDICO-HOSPITALARES LTDA São Paulo, SP | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, In-vitro diagnostics +2 more | 231 | 163 | 45 | 82.0 | 4/5 |
| 17 | SG TECNOLOGIA CLÍNICA LTDA São Paulo, SP | Maker's own entity Importer, Distributor, Registration holder, Exporter | Aesthetics, dermatology and lasers, General hospital and consumables, Gastroenterology, urology and OB/GYN +3 more | 104 | 103 | 34 | 73.8 | 5/5 |
| 18 | BOSTON SCIENTIFIC DO BRASIL LTDA São Paulo, SP | Maker's own entity Importer, Distributor, Registration holder, Exporter | Aesthetics, dermatology and lasers, Cardiovascular, General hospital and consumables +6 more | 709 | 418 | 42 | 87.4 | 5/5 |
| 19 | ARTHREX DO BRASIL IMPORTACAO E COMERCIO DE EQUIPAMENTOS MÉDICOS LTDA São Paulo, SP | Maker's own entity Importer, Distributor, Registration holder, Exporter | Aesthetics, dermatology and lasers, General hospital and consumables, Gastroenterology, urology and OB/GYN +3 more | 365 | 275 | 33 | 83.1 | 4/5 |
| 20 | SOL-MILLENNIUM BRASIL IMPORTACAO E EXPORTACAO LTDA Ribeirão Preto, SP | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +3 more | 196 | 195 | 30 | 80.5 | 5/5 |
Questions about in-vitro diagnostics distributors in Brazil
How many in-vitro diagnostics distributors are there in Brazil?
The Index counts 747 establishments in Brazil with in-vitro diagnostics in their registry record, of which 300 are independent distributors (a channel role and no manufacturing of their own). The number comes from ANVISA Brazil, US FDA (openFDA), MHRA UK and Health Canada 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
General hospital and consumables 2,081Surgery and endoscopy 1,720Orthopaedics, spine and trauma 959Cardiovascular 674Dental 618Anaesthesia and respiratory 556Patient monitoring and neurology 479Imaging, radiology and radiotherapy 458Aesthetics, dermatology and lasers 420Gastroenterology, urology and OB/GYN 408Ear, nose and throat 350Ophthalmic 287
In-vitro diagnostics in other Latin America and the Caribbean markets
Sources
- Brazil ANVISA medical device registrations, open data portal: 739 establishments, last seen 23 October 2026. Brazilian government open data.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 23 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 4 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 1 establishments, last seen 23 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.