GLYCATED HEMOGLOBIN (HbA1C) - ANVISA Registration 80105220143
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 80105220143 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
80105220143
25351409531202318
04299232000143
Company Information
Dates and Status
Jul 24, 2023
VIGENTE
09/18/2025 19:00:01
GLYCATED HEMOGLOBIN (HbA1C)
FASTLINE FIA HbA1c
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220189
May 13, 2024
GLYCATED HEMOGLOBIN (HbA1C)
Fast Test HbA1c H-Plus
QINGDAO HIGHTOP BIOTECH CO.,LTD.
82533950060
May 06, 2024
GLYCATED HEMOGLOBIN (HbA1C)
one HbA1c FS
DIASYS DIAGNOSTIC SYSTEMS GMBH & CO
10350840195
Dec 07, 2010
GLYCATED HEMOGLOBIN (HbA1C)
HbA1c
VYTTRA DIAGNOSTICOS S.A.
81692610203
Oct 22, 2020
GLYCATED HEMOGLOBIN (HbA1C)
HbA1c
ERBA LACHEMA S.R.O.
81826160081
Jan 14, 2021
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