GLYCATED HEMOGLOBIN (HbA1C) - ANVISA Registration 82444370046
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 82444370046 and manufactured by DIAZYME LABORATORIES, INC.. The registration is held by Enzytec Biotecnologia 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
82444370046
25351216440202322
07214566000165
Company Information
Dates and Status
May 15, 2023
VIGENTE
09/18/2025 19:00:01
GLYCATED HEMOGLOBIN (HbA1C)
Família Cassete de Teste de HbA1c (Sangue Total)
ACRO BIOTECH, INC. (MONTCLAIR)
81325990176
Apr 22, 2021
GLYCATED HEMOGLOBIN (HbA1C)
Família A1cChek Pro Kit
WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO., LTD.
81464750132
Aug 14, 2023
GLYCATED HEMOGLOBIN (HbA1C)
HbA1c Fast Test kit (Ensaio de Imunofluorescência)
GETEIN BIOTECH INC.
80464810506
Jun 05, 2017
GLYCATED HEMOGLOBIN (HbA1C)
Família de Coluna Cromatográfica para Ensaio de HbA1c (HPLC)
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
80474870141
Aug 28, 2023
GLYCATED HEMOGLOBIN (HbA1C)
TESTE RÁPIDO HEMOGLOBINA GLICADA (HbA1c)
GETEIN BIOTECH INC.
80583710011
Sep 11, 2017
HEMOGLOBINA GLICADA (HbA1C)
Família 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)
Família Coluna analítica 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