GLYCATED HEMOGLOBIN (HbA1C) - ANVISA Registration 10345162339
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 10345162339 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.. The registration is held by SIEMENS HEALTHCARE DIAGNÓSTICOS 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
10345162339
25351317367201929
01449930000190
Company Information
Dates and Status
Nov 11, 2019
VIGENTE
09/18/2025 19:00:01
GLYCATED HEMOGLOBIN (HbA1C)
Família HbA1c FIA (Sangue Total)
HANGZHOU ALLTEST BIOTECH CO. LTD
81325990338
Mar 11, 2024
GLYCATED HEMOGLOBIN (HbA1C)
Familia Atellica CH Hemoglobina A1c Enzimática (A1c_E)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
10345162334
Oct 07, 2019
GLYCATED HEMOGLOBIN (HbA1C)
Família Alinity c Hemoglobin A1c
ABBOTT GMBH
80146502158
Jul 30, 2018
GLYCATED HEMOGLOBIN (HbA1C)
Família AFIAS HbA1c
BODITECH MED INC.
10350840313
Jun 11, 2018
GLYCATED HEMOGLOBIN (HbA1C)
Família Diazyme Direct HbA1c (Enzymatic, On-Board Lysis)
DIAZYME LABORATORIES, INC.
82444370046
May 15, 2023
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