GLYCATED HEMOGLOBIN (HbA1C) - ANVISA Registration 10300390127
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 10300390127 and manufactured by BIOSYSTEMS S.A. The registration is held by VYTTRA DIAGNOSTICOS S.A. 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
Need help with your Brazil registration?
Contact Pure Global Brazil TeamDevice Details
Registration Details
10300390127
25351747689201818
00904728000148
Company Information
Dates and Status
Dec 17, 2018
VIGENTE
09/18/2025 19:00:01
GLYCATED HEMOGLOBIN (HbA1C)
CONTROLE DE HEMOGLOBINA GLICADA NIVEL 1 E 2
RANDOX LABORATORIES LTD.
80158990079
Feb 09, 2005
GLYCATED HEMOGLOBIN (HbA1C)
HbA1c Fast Test kit (Ensaio de Imunofluorescência)
GETEIN BIOTECH INC.
80464810506
Jun 05, 2017
GLYCATED HEMOGLOBIN (HbA1C)
TESTE RÁPIDO HEMOGLOBINA GLICADA (HbA1c)
GETEIN BIOTECH INC.
80583710011
Sep 11, 2017
GLYCATED HEMOGLOBIN (HbA1C)
Controle HbA1c
QUIBASA QUÍMICA BÁSICA LTDA
10269360177
Oct 05, 2009
GLYCATED HEMOGLOBIN (HbA1C)
Controle HbA1c
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
80474870094
May 26, 2022
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