Visit us at Medica, Dusseldorf, Germany 17-20 November 2025 at Hall 16, Stand D17-5 and ask us about our free AI tools and the document builder.
Pure Global

This comprehensive analysis showcases hematology and pathology medical devices registered with Brazil's ANVISA, powered by AI semantic search across 100,000+ products. 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 2,864 hematology/pathology device registrations from 623 global manufacturers held by 262 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.

Hematology / Pathology Medical Devices

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

2,864
Total Devices
623
Manufacturers
262
Reg. Holders
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Free consultation
Registration Trends
Quarterly activity (last 4 years)
Q4'21
41
Q1'22
34
Q2'22
28
Q3'22
30
Q4'22
51
Q1'23
61
Q2'23
39
Q3'23
60
Q4'23
58
Q1'24
69
Q2'24
39
Q3'24
41
Q4'24
45
Q1'25
68
Q2'25
51
Q3'25
57
Recent Registrations
Latest 10 hematology / pathology device registrations

BLOOD CELL COUNT

Class II
Sep 15, 2025

Kit Xpress para Hemograma Completo com Diferenciação de 5 Tipos de Leucócitos

Mfr: MYLAB DISCOVERY SOLUTIONS PVT LTD.Holder: COUSANDIER EMPRESARIAL LTDA

Instrument for cell and platelet analysis or counting

Class II
Sep 15, 2025

Família Analisador Hematológico

Mfr: EDAN INSTRUMENTS, INC.Holder: MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA

CYTOLOGICAL STAINS

Class I
Sep 15, 2025

Corante M-6FM

Mfr: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTDHolder: MINDRAY DO BRASIL COMÉRCIO E DISTRIBUIÇÃO DE EQUIPAMENTOS MÉDICOS LTDA.

Instrument for hemostasis

Class II
Sep 15, 2025

Família Analisadores CN

Mfr: SYSMEX CORPORATIONHolder: SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA

Instrument for cell and platelet analysis or counting

Class II
Sep 15, 2025

Família Analisador Automático de Hematologia

Mfr: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTDHolder: MINDRAY DO BRASIL COMÉRCIO E DISTRIBUIÇÃO DE EQUIPAMENTOS MÉDICOS LTDA.

CALPROTECTIN

Class II
Sep 15, 2025

Calprotectin Quality Control (Quantitative)

Mfr: ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.Holder: LATIN HEALTH IMPORTADORA E DISTRIBUIDORA LTDA.

Absorbable Hemostatics

Class IV
Sep 15, 2025

HEMALIMIT

Mfr: N/AHolder: DR IMPORTAÇÃO, EXPORTAÇÃO E DISTRIBUIÇÃO LTDA

Absorbable Hemostatics

Class IV
Sep 15, 2025

HEMALIMIT

Mfr: EOS MEDICAL SOLUTIONSHolder: DR IMPORTAÇÃO, EXPORTAÇÃO E DISTRIBUIÇÃO LTDA

Instrument for cell and platelet analysis or counting

Class II
Sep 08, 2025

Família de Analisadores Semi-Automáticos de Hematologia Blood 5P Jr

Mfr: IN VITRO DIAGNOSTICA LTDAHolder: IN VITRO DIAGNOSTICA LTDA

Instrument for cell and platelet analysis or counting

Class II
Sep 08, 2025

Família de Analisadores Semi-Automáticos de Hematologia Blood 3P

Mfr: IN VITRO DIAGNOSTICA LTDAHolder: IN VITRO DIAGNOSTICA LTDA
Risk Class Distribution
Distribution by ANVISA risk classification
409
Class I
1,816
Class II
449
Class III
190
Class IV