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Registry insights · ANVISA

Clinical Chemistry Medical Devices in Brazil

AI-powered insights on clinical chemistry devices registered with Brazil ANVISA.

8,396
Device registrations
899
Manufacturers
289
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 clinical chemistry device registrations published by ANVISA
CREATINE KINASE ISOENZYMES (CKMB, CKBB, CKMM)
BIOCLIN POCT FIA CK-MB
Sep 15, 2025Class III
Manufacturer
QUIBASA QUÍMICA BÁSICA LTDA
Holder
QUIBASA - QUIMICA BASICA LTDA
Registration
10269360481
HUMAN CHORIONIC BETA GONADOTROPIN (BHCG)
ß-HCG FIA Analyzer Test
Sep 15, 2025Class II
Manufacturer
GUANGZHOU BIOSURPASS BIOTECHNOLOGY CO., LTD
Holder
Diagnóstica Indústria e Comércio LTDA
Registration
82102680001
HUMAN BRAIN NATRIURETIC PEPTIDE (BNP)
ADVIA Centaur NT-proBNPII (PBNPII)
Sep 15, 2025Class III
Manufacturer
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Holder
SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA
Registration
10345162547
FITA-TESTE PARA URINA
MC Urinalysis Strip – CA-11
Sep 15, 2025Class II
Manufacturer
CHANGCHUN MEDICSIDE MEDICAL TECHNOLOGY CO. LTD.
Holder
GOYAZES BIOTECNOLOGIA LTDA
Registration
80345000342
ANDROSTENEDIONE
Família MAGLUMI Androstenedione (CLIA)
Sep 15, 2025Class II
Manufacturer
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
Holder
VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA
Registration
80102513517
REVERSE TRIIODOTHYRONINE (T3)
Maglumi Familia Rev T3 (CLIA)
Sep 15, 2025Class II
Manufacturer
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
Holder
VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA
Registration
80102513523
FITA-TESTE PARA URINA
MC Urinalysis Strip – CA-10
Sep 15, 2025Class II
Manufacturer
CHANGCHUN MEDICSIDE MEDICAL TECHNOLOGY CO. LTD.
Holder
GOYAZES BIOTECNOLOGIA LTDA
Registration
80345000340
HEMOGLOBINA GLICADA (HbA1C)
Família Turb HbA1c – Hemoglobina Glicada
Sep 15, 2025Class II
Manufacturer
EBRAM PRODUTOS LABORATORIAIS LTDA
Holder
EBRAM PRODUTOS LABORATORIAIS LTDA
Registration
10159820269
TROPONIN
BIOCLIN POCT FIA TROPONINA I
Sep 15, 2025Class III
Manufacturer
QUIBASA QUÍMICA BÁSICA LTDA
Holder
QUIBASA - QUIMICA BASICA LTDA
Registration
10269360479
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
About the data

Clinical Chemistry devices in the ANVISA registry

This comprehensive analysis showcases clinical chemistry medical devices registered with Brazil’s ANVISA, identified through semantic classification of 89,072 current registrations (88.9% of the current registration-number index). Clinical chemistry devices include chemistry analyzers, blood gas analyzers, electrolyte analyzers, glucose meters, metabolic testing equipment, laboratory automation systems, point-of-care testing devices, and diagnostic reagents essential for measuring biochemical markers and monitoring patient health status.

Our AI analysis identified 8,396 clinical chemistry device registrations from 899 global manufacturers held by 289 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 clinical laboratory market.

Understanding the clinical chemistry 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 · 8,396 semantically classified registrations
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context: country=brazil · specialty=Clinical Chemistry
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