GLYCATED HEMOGLOBIN (HbA1C) - ANVISA Registration 10287411365
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 10287411365 and manufactured by ROCHE DIAGNOSTICS GMBH. The registration is held by ROCHE DIAGNÓSTICA BRASIL 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
10287411365
25351022197201905
30280358000186
Company Information
Dates and Status
Mar 18, 2019
VIGENTE
09/18/2025 19:00:01
GLYCATED HEMOGLOBIN (HbA1C)
Cobas HbA1c Test
ROCHE DIAGNOSTICS GMBH
10287411047
Jun 02, 2014
GLYCATED HEMOGLOBIN (HbA1C)
cobas HbA1c Control
ROCHE DIAGNOSTICS GMBH
10287411054
Jul 21, 2014
GLYCATED HEMOGLOBIN (HbA1C)
HbA1c
ERBA LACHEMA S.R.O.
81826160081
Jan 14, 2021
GLYCATED HEMOGLOBIN (HbA1C)
HbA1c
BECKMAN COULTER, INC.
10033120912
Apr 06, 2015
GLYCATED HEMOGLOBIN (HbA1C)
HbA1c
GT LABORATORIOS SRL
80538800001
Apr 20, 2015
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