GLYCATED HEMOGLOBIN (HbA1C) - ANVISA Registration 81826160099
Access comprehensive regulatory information for GLYCATED HEMOGLOBIN (HbA1C) in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 81826160099 and manufactured by ERBA LACHEMA S.R.O. The registration is held by ERBA DIAGNOSTICS BRAZIL, PRODUCAO E DISTRIBUICAO DE PRODUTOS MEDICOS LTDA with validity until currently active (VIGENTE).
This page provides complete technical specifications for this device, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD., ROCHE DIAGNOSTICS GMBH, and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Registration Details
81826160099
25351335067202499
32190515000198
Company Information
Dates and Status
Jul 08, 2024
VIGENTE
09/18/2025 19:00:01
GLYCATED HEMOGLOBIN (HbA1C)
FamĂlia Controle HbA1c NĂvel 2
GOLDSITE DIAGNOSTICS INC.
82561270004
Apr 15, 2024
GLYCATED HEMOGLOBIN (HbA1C)
FAMĂŤLIA CONTROLE HbA1C
BIOANALÍTICA DIAGNÓSTICA LTDA
81666810038
Aug 19, 2019
GLYCATED HEMOGLOBIN (HbA1C)
FamĂlia Controle de Hemoglobina Glicada (HPLC)
LABNOVATION TECHNOLOGIES, INC.
80785070251
Jan 02, 2024
GLYCATED HEMOGLOBIN (HbA1C)
FamĂlia Controle HbA1c NĂvel 1
GOLDSITE DIAGNOSTICS INC.
82561270003
Apr 15, 2024
GLYCATED HEMOGLOBIN (HbA1C)
FamĂlia de Controle e PadrĂŁo de HbA1C
BIOSYSTEMS S.A.
80367750173
Jan 23, 2023
HEMOGLOBINA GLICADA (HbA1C)
FamĂlia Turb HbA1c – Hemoglobina Glicada
EBRAM PRODUTOS LABORATORIAIS LTDA
10159820269
Sep 15, 2025
HEMOGLOBINA GLICADA (HbA1C)
Tina-quant Hemoglobin A1cDx Gen.3
ROCHE DIAGNOSTICS GMBH
10287411760
Sep 08, 2025
HEMOGLOBINA GLICADA (HbA1C)
FamĂlia Coluna analĂtica para hemoglobina A1c
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
80943610286
Sep 01, 2025
HEMOGLOBINA GLICADA (HbA1C)
HbA1c Assure FIA Test
ASSURE TECH. (HANGZHOU) CO., LTD
80885650094
Sep 01, 2025
HEMOGLOBINA GLICADA (HbA1C)
Luminis FIA HbA1c
QINGDAO HIGHTOP BIOTECH CO.,LTD.
80474870159
Jul 07, 2025