Immunology / Microbiology Medical Devices in Brazil
AI-powered insights on immunology / microbiology devices registered with Brazil ANVISA.
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Top 10 Manufacturers
Leading manufacturers in immunology / microbiology devices
| Rank | Manufacturer | Devices |
|---|---|---|
#1 | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG(Germany) | 93 |
#2 | ORGENTEC DIAGNOSTIKA GMBH(Germany) | 85 |
#3 | ROCHE DIAGNOSTICS GMBH(Germany) | 78 |
#4 | Eco Diagnostica Ltda(Brazil) | 76 |
#5 | VIRCELL S.L.(Spain) | 66 |
#6 | PHADIA AB(Sweden) | 63 |
#7 | KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA(Brazil) | 61 |
#8 | DIA.PRO DIAGNOSTIC BIOPROBES SRL(Italy) | 60 |
#9 | DIASORIN ITALIA S.P.A.(Italy) | 57 |
#10 | EUROIMMUN AG(Germany) | 55 |
Top 10 Registration Holders
Companies holding most immunology / microbiology registrations
Top 10 Products
Most registered product types — each links to a database search
| Rank | Product type | Registrations |
|---|---|---|
#1 | CORONAVIRUS | 316 |
#2 | Instrument intended for immunoassays | 133 |
#3 | ANTINUCLEAR ANTIBODY (ANA) | 119 |
#4 | DENGUE | 103 |
#5 | COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II | 78 |
#6 | TOXOPLASMA GONDII | 77 |
#7 | IMMUNOGLOBULIN E | 73 |
#8 | HERPES VIRUS (HHV 5) - CYTOMEGALOVIRUS | 71 |
#9 | RHEUMATOID FACTOR | 69 |
#10 | HELICOBACTER PYLORI | 61 |
- Manufacturer
- ZHEJIANG ORIENT GENE BIOTECH CO., LTD.
- Holder
- Enzytec Biotecnologia Ltda.
- Registration
- 82444370273
- Manufacturer
- LABTEST DIAGNOSTICA S/A
- Holder
- LABTEST DIAGNOSTICA S/A
- Registration
- 10009010503
- Manufacturer
- AESKU DIAGNOSTICS GMBH & CO. KG
- Holder
- NACH BRASIL PRODUTOS DIAGNOSTICOS LTDA
- Registration
- 82910510005
- Manufacturer
- R-BIOPHARM AG
- Holder
- R-BIOPHARM BRASIL COMERCIO DE PRODUTOS PARA ANALISE DE ALIMENTOS LTDA
- Registration
- 82890930018
- Manufacturer
- KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
- Holder
- KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
- Registration
- 80105220288
- Manufacturer
- ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.
- Holder
- LATIN HEALTH IMPORTADORA E DISTRIBUIDORA LTDA.
- Registration
- 81778810046
- Manufacturer
- ARTRON LABORATORIES INC.
- Holder
- GENESTAR INOVAÇÕES E EQUIPAMENTOS MÉDICOS LTDA
- Registration
- 82149920136
- Manufacturer
- HIMEDIA LABORATORIES PVT.LTD.
- Holder
- PASSROD IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS PARA SAÚDE LTDA - ME
- Registration
- 81504790516
- Manufacturer
- LABTEST DIAGNOSTICA S/A
- Holder
- LABTEST DIAGNOSTICA S/A
- Registration
- 10009010501
- Manufacturer
- QINGDAO HIGHTOP BIOTECH CO.,LTD.
- Holder
- BIOSUL PRODUTOS DIAGNOSTICOS LTDA - ME
- Registration
- 80474870165
Immunology / Microbiology devices in the ANVISA registry
This comprehensive analysis showcases immunology and microbiology medical devices registered with Brazil’s ANVISA, identified through semantic classification of 89,072 current registrations (88.9% of the current registration-number index). Immunology and microbiology devices include immunoassay systems, microbial identification platforms, culture media and systems, serology analyzers, molecular diagnostics, infectious disease testing equipment, rapid test kits, and laboratory automation essential for diagnosing infections, monitoring immune responses, and ensuring patient safety.
Our AI analysis identified 3,627 immunology/microbiology device registrations from 566 global manufacturers held by 231 registration holders in Brazil. The rankings below reveal market leaders, emerging players, quarterly registration trends, most common product types, and recent ANVISA approvals—providing actionable competitive intelligence for manufacturers, distributors, and regulatory professionals targeting Brazil’s immunology and microbiology market.
Understanding the immunology and microbiology device landscape in Brazil helps companies identify partnership opportunities, benchmark market positioning, assess competitive dynamics, and develop market entry strategies. Pure Global AI’s semantic search technology categorizes devices by medical specialty automatically, delivering specialized market intelligence completely free.
Specialty assignment is a derived semantic classification, not an ANVISA-published field. A registration can reasonably appear in more than one specialty, so specialty totals should not be added together. Every displayed registration, holder, manufacturer, risk class, and publication date is resolved back to the current ANVISA registry snapshot; registrations not yet present in the semantic index are excluded.