GLYCATED HEMOGLOBIN (HbA1C) - ANVISA Registration 80885650094
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 80885650094 and manufactured by ASSURE TECH. (HANGZHOU) CO., LTD. The registration is held by ORBITAE DIAGNOSTICOS 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
80885650094
25351117459202559
11162384000165
Company Information
Dates and Status
Sep 01, 2025
VIGENTE
09/18/2025 19:00:01
GLYCATED HEMOGLOBIN (HbA1C)
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GLYCATED HEMOGLOBIN (HbA1C)
FIA HbA1c
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GLYCATED HEMOGLOBIN (HbA1C)
Flow HbA1c FIA
HI TECHNOLOGIES LTDA
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GLYCATED HEMOGLOBIN (HbA1C)
FASTLINE FIA HbA1c
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80105220189
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GLYCATED HEMOGLOBIN (HbA1C)
Luminis FIA HbA1c
QINGDAO HIGHTOP BIOTECH CO.,LTD.
80474870159
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HEMOGLOBINA GLICADA (HbA1C)
Família Turb HbA1c – Hemoglobina Glicada
EBRAM PRODUTOS LABORATORIAIS LTDA
10159820269
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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)
Luminis FIA HbA1c
QINGDAO HIGHTOP BIOTECH CO.,LTD.
80474870159
Jul 07, 2025
HEMOGLOBINA GLICADA (HbA1C)
BIOCLIN POCT FIA HbA1c
QUIBASA QUÍMICA BÁSICA LTDA
10269360468
Jun 09, 2025