CELIAC DISEASE ANTIBODY SELF-TEST - ANVISA Registration 80686360311
Access comprehensive regulatory information for CELIAC DISEASE ANTIBODY SELF-TEST in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80686360311 and manufactured by BIOSYNEX SA. The registration is held by MANDALA BRASIL IMPORTACAO E DISTRIBUICAO DE PRODUTO MEDICO HOSPITALAR 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, 2 companies making the same product including VEDALAB, CHEMBIO DIAGNOSTICS BRAZIL LTDA., and 3 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
80686360311
25351046046202159
09117476000181
Company Information
Dates and Status
Feb 25, 2021
VIGENTE
09/18/2025 19:00:01
CELIAC DISEASE ANTIBODY SELF-TEST
Biosynex Teste de Glúten
CHEMBIO DIAGNOSTICS BRAZIL LTDA.
80535240072
Dec 23, 2024
SELF-TEST FOR GLUCOSE
FAMÍLIA PARA TESTE DE GLICOSE SANGUINEA OK PRO
OK BIOTECH CO., LTD.
80867150139
Mar 20, 2023
SELF-TEST FOR GLUCOSE
FAMÍLIA PARA TESTE DE GLICOSE SANGUINEA OK PRO
Not specified
80867150139
Mar 20, 2023
SELF-TEST FOR GLUCOSE
FAMÍLIA TIRAS TESTE DE GLICEMIA
TAIDOC TECHNOLOGY CORPORATION
81230160007
Jun 11, 2018
SELF-TEST FOR GLUCOSE
FAMÍLIA TIRAS TESTE DE GLICEMIA
Not specified
81230160007
Jun 11, 2018
AUTOTESTE PARA ANTICORPO PARA DOENÇA CELÍACA
Biosynex Teste de Glúten
CHEMBIO DIAGNOSTICS BRAZIL LTDA.
80535240072
Dec 23, 2024
AUTOTESTE PARA ANTICORPO PARA DOENÇA CELÍACA
Gluten’ Alarm® Homeuse
VEDALAB
80464810865
Dec 04, 2023
AUTOTESTE PARA ANTICORPO PARA DOENÇA CELÍACA
GLUTEN’ALARM® Homeuse
VEDALAB
81086830053
Jan 16, 2023