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Registry insights · ANVISA

Hematology / Pathology Medical Devices in Brazil

AI-powered insights on hematology / pathology devices registered with Brazil ANVISA.

2,741
Device registrations
594
Manufacturers
253
Registration holders
DJ Fang
DJ Fang
MedTech Regulatory Expert

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AI inferredANVISA registry · data as of 2026-08-26 · 88.9% semantic-index coverage
Registrations by ANVISA risk class
Class IClass IIClass IIIClass IV
AI inferredANVISA registry · data as of 2026-08-26 · 88.9% semantic-index coverage

Top 10 Products

Most registered product types — each links to a database search

Recent registrations
Latest 10 hematology / pathology device registrations published by ANVISA
BLOOD CELL COUNT
Kit Xpress para Hemograma Completo com Diferenciação de 5 Tipos de Leucócitos
Sep 15, 2025Class II
Manufacturer
MYLAB DISCOVERY SOLUTIONS PVT LTD.
Holder
COUSANDIER EMPRESARIAL LTDA
Registration
82968070002
Instrument for cell and platelet analysis or counting
Família Analisador Hematológico
Sep 15, 2025Class II
Manufacturer
EDAN INSTRUMENTS, INC.
Holder
MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA
Registration
80047300903
CYTOLOGICAL STAINS
Corante M-6FM
Sep 15, 2025Class I
Manufacturer
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Holder
MINDRAY DO BRASIL COMÉRCIO E DISTRIBUIÇÃO DE EQUIPAMENTOS MÉDICOS LTDA.
Registration
80943610297
Instrument for hemostasis
Família Analisadores CN
Sep 15, 2025Class II
Manufacturer
SYSMEX CORPORATION
Holder
SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA
Registration
10345162543
Instrument for cell and platelet analysis or counting
Família Analisador Automático de Hematologia
Sep 15, 2025Class II
Manufacturer
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Holder
MINDRAY DO BRASIL COMÉRCIO E DISTRIBUIÇÃO DE EQUIPAMENTOS MÉDICOS LTDA.
Registration
80943610293
CALPROTECTIN
Calprotectin Quality Control (Quantitative)
Sep 15, 2025Class II
Manufacturer
ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.
Holder
LATIN HEALTH IMPORTADORA E DISTRIBUIDORA LTDA.
Registration
81778810046
Absorbable Hemostatics
HEMALIMIT
Sep 15, 2025Class IV
Manufacturer
EOS MEDICAL SOLUTIONS
Holder
DR IMPORTAÇÃO, EXPORTAÇÃO E DISTRIBUIÇÃO LTDA
Registration
80991380100
Instrument for cell and platelet analysis or counting
Família de Analisadores Semi-Automáticos de Hematologia Blood 5P Jr
Sep 08, 2025Class II
Manufacturer
IN VITRO DIAGNOSTICA LTDA
Holder
IN VITRO DIAGNOSTICA LTDA
Registration
10303460563
Instrument for cell and platelet analysis or counting
Família de Analisadores Semi-Automáticos de Hematologia Blood 3P
Sep 08, 2025Class II
Manufacturer
IN VITRO DIAGNOSTICA LTDA
Holder
IN VITRO DIAGNOSTICA LTDA
Registration
10303460564
BLOOD CELL COUNT
Família Controle Hematológico
Sep 08, 2025Class II
Manufacturer
EDAN INSTRUMENTS, INC.
Holder
MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA
Registration
80047300901
About the data

Hematology / Pathology devices in the ANVISA registry

This comprehensive analysis showcases hematology and pathology medical devices registered with Brazil’s ANVISA, identified through semantic classification of 89,072 current registrations (88.9% of the current registration-number index). Hematology and pathology devices include hematology analyzers, coagulation instruments, cell counters, blood bank equipment, microscopes, pathology workstations, slide stainers, tissue processors, and diagnostic reagents essential for blood testing, disease diagnosis, and laboratory medicine.

Our AI analysis identified 2,741 hematology/pathology device registrations from 594 global manufacturers held by 253 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 hematology and pathology market.

Understanding the hematology and pathology 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.

AI inferredANVISA · data as of 2026-08-26 · 2,741 semantically classified registrations
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context: country=brazil · specialty=Hematology / Pathology
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