Updated 22 October 2026
Medical device distributors in Brazil: 112 licensed establishments
The Bastion Hale Distributor Index lists 112 medical device establishments registered with an address in Brazil: 7 with a channel role (importer, distributor, wholesaler or authorised representative), 5 registration holders without a channel role, and 100 registered as manufacturer or exporter only. The records come from US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
By segment
| Segment | Establishments | |
|---|---|---|
| Surgery and endoscopy | 37 | Search in the Index |
| Orthopaedics, spine and trauma | 16 | Search in the Index |
| Cardiovascular | 5 | Search in the Index |
| Ear, nose and throat | 7 | Search in the Index |
| Gastroenterology, urology and OB/GYN | 15 | Search in the Index |
| Dental | 43 | Search in the Index |
| Anaesthesia and respiratory | 11 | Search in the Index |
| Patient monitoring and neurology | 19 | Search in the Index |
| Ophthalmic | 11 | Search in the Index |
| In-vitro diagnostics | 12 | Search in the Index |
| General hospital and consumables | 27 | Search in the Index |
| Aesthetics, dermatology and lasers | 5 | Search in the Index |
| Imaging, radiology and radiotherapy | 5 | 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; Bastion Hale's launch services do not cover them.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 7 | 6% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 6 | 5% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 105 | 94% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 16 | 14% | 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.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later; the Audit covers it per market.
Top 20 establishments by size
Channel roles (importer, distributor, wholesaler, authorised representative) are listed first, then registration holders, then manufacturers. Size is a 0 to 100 score built from products listed, registrations held, roles, sources and principals represented. Complete is 0 to 5 for website, address, segments, principals and counts.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | S.I.N. Implant System Ltda SAO PAULO | Channel Distributor, Registration holder, Manufacturer | General hospital and consumables, Dental, Orthopaedics, spine and trauma +1 more | 164 | 18 | 0 | 56.7 | 3/5 |
| 2 | Ortho Pauher Ind. Com. E Dist. Ltda Recife Pernambuco | Channel Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Gastroenterology, urology and OB/GYN +2 more | 17 | 1 | 0 | 31.5 | 3/5 |
| 3 | ADITEK DO BRASIL, SA CRAVINHOS Sao Paulo | Channel Distributor, Manufacturer | Dental | 13 | 1 | 0 | 28.6 | 3/5 |
| 4 | Luxottica Brasil Produtos Oticos E Esportivos Ltda. CAMPINAS Sao Paulo | Channel Distributor, Manufacturer, Exporter | Ophthalmic | 6 | 2 | 0 | 28.6 | 3/5 |
| 5 | AGAPLASTIC IND. COM. LTDA. RIO DE JANEIRO | Channel Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +1 more | 8 | 1 | 0 | 27.9 | 3/5 |
| 6 | DFL INDUSTRIA E COMERCIO SA Rio de Janeiro | Channel Distributor, Manufacturer | Dental | 6 | 1 | 0 | 25.1 | 3/5 |
| 7 | ANDRE GREGATE BRAGA INSTRUMENTOS LTDA CAIEIRAS Sao Paulo | Channel Distributor, Manufacturer | Dental | 1 | 1 | 0 | 18.7 | 3/5 |
| 8 | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A. Curitiba Parana | Holder Registration holder, Manufacturer | General hospital and consumables, Dental, Ear, nose and throat +2 more | 475 | 25 | 0 | 61.9 | 3/5 |
| 9 | VYDENCE MEDICAL - INDUSTRIA E COMERCIO LTDA CEAT - Sao Carlos/SP Sao Paulo | Holder Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Patient monitoring and neurology, Surgery and endoscopy | 28 | 5 | 0 | 42.4 | 3/5 |
| 10 | ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS S/A Londrina | Holder Registration holder, Manufacturer | Dental | 16 | 9 | 0 | 37.1 | 3/5 |
| 11 | DENTSCARE LTDA Joinville Santa Catarina | Holder Registration holder, Manufacturer | General hospital and consumables, Dental | 17 | 2 | 0 | 35.2 | 3/5 |
| 12 | 3R INDUSTRIA E COMERCIO LTDA SAO PAULO | Holder Registration holder, Manufacturer | Dental, Surgery and endoscopy | 8 | 4 | 0 | 34.0 | 3/5 |
| 13 | H. Strattner Palhoca Santa Catarina | Manufacturer Exporter | General hospital and consumables, Ear, nose and throat, Gastroenterology, urology and OB/GYN +2 more | 200 | 2 | 0 | 41.7 | 3/5 |
| 14 | 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 |
| 15 | SCHOBELL INDUSTRIAL LTDA Rio Claro Sao Paulo | Manufacturer Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +5 more | 87 | 1 | 0 | 35.6 | 3/5 |
| 16 | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS LONDRINA Parana | Manufacturer Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +2 more | 29 | 1 | 0 | 32.4 | 3/5 |
| 17 | ITM Industria de Tecnologias Medicas LTDA CANOAS Rio Grande do Sul | Manufacturer Manufacturer | Cardiovascular, General hospital and consumables, Dental +6 more | 45 | 1 | 0 | 32.3 | 3/5 |
| 18 | CURITIBA ESTERILIZACAO DE MATERIAIS MEDICOS LTDA Pinhais Parana | Manufacturer Manufacturer | Dental | 36 | 1 | 0 | 31.2 | 3/5 |
| 19 | GM DOS REIS INDUSTRIA E COMERCIO LTDA Campinas Sao Paulo | Manufacturer Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 33 | 1 | 0 | 30.8 | 3/5 |
| 20 | ORTOFACE COSMETICOS E PRODUTOS PARA SAUDE LTDA Salto Sao Paulo | Manufacturer Exporter | Orthopaedics, spine and trauma, Surgery and endoscopy | 33 | 1 | 0 | 30.8 | 3/5 |
Questions about medical device distributors in Brazil
How many medical device distributors are there in Brazil?
The Index counts 112 medical device establishments registered in Brazil, of which 7 hold a channel role as importer, distributor, wholesaler or authorised representative. The rest are registration holders or manufacturers. The number comes from US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a medical 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 medical device distributor in Brazil?
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 Brazil to see the counts for your segment and reveal three profiles. For a shortlist with our read on each name, book the International Launch Audit.
What does the Distributor Index count as a distributor in Brazil?
An establishment is a company that appears in a public regulatory registry with an address in Brazil, 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.
Segment pages for Brazil
Related markets in Latin America and the Caribbean
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 111 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 6 establishments, last seen 22 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.