GLYCATED HEMOGLOBIN (HbA1C) - ANVISA Registration 80105220189
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 80105220189 and manufactured by KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA. The registration is held by KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS 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
80105220189
25351212175202494
04299232000143
Company Information
Dates and Status
May 13, 2024
VIGENTE
09/18/2025 19:00:01
GLYCATED HEMOGLOBIN (HbA1C)
FASTLINE HbA1c
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220143
Jul 24, 2023
GLYCATED HEMOGLOBIN (HbA1C)
FIA HbA1c
GOLD ANALISA DIAGNOSTICA LTDA
80022230245
May 19, 2022
GLYCATED HEMOGLOBIN (HbA1C)
Flow HbA1c FIA
HI TECHNOLOGIES LTDA
80583710044
Aug 07, 2023
GLYCATED HEMOGLOBIN (HbA1C)
HbA1c FIA Analyzer Test
BIFOUR BIOTECH INC.
80638720240
Mar 04, 2024
GLYCATED HEMOGLOBIN (HbA1C)
Hb1Ac Test Cassete FIA
HANGZHOU ALLTEST BIOTECH CO., LTD
80638720146
Mar 09, 2020
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