ENTAMOEBA SP - ANVISA Registration 80826840118
Access comprehensive regulatory information for ENTAMOEBA SP in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80826840118 and manufactured by R-BIOPHARM AG. The registration is held by SERION BRASIL IMPORTAÇÃO E DISTRIBUIÇÃO DE PRODUTOS DIAGNÓSTICOS 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 R-BIOPHARM AG, ACRO BIOTECH, INC. (MONTCLAIR), 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
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Registration Details
80826840118
25351580806201938
14021899000133
Company Information
Dates and Status
Oct 21, 2019
VIGENTE
09/18/2025 19:00:01
ENTAMOEBA SP
Entamoeba histolytica IgG - ELISA
NOVATEC
80464810505
May 29, 2017
ENTAMOEBA SP
RIDASCREEN ENTAMOEBA
R-BIOPHARM
80826840125
Oct 21, 2019
ENTAMOEBA SP
RIDASCREEN® Entamoeba
R-BIOPHARM AG
82890930008
Apr 28, 2025
ENTAMOEBA SP
E. histolytica/dispar Antigen Detection Assay Microwell ELISA
IVD RESEARCH INC
10259610093
Jan 18, 2010
ENTAMOEBA SP
FASTLINE ENTAMOEBA HISTOLYTICA Ag
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220121
Mar 13, 2023
R-BIOPHARM AG• Germany
ACRO BIOTECH, INC. (MONTCLAIR)• United States of America
HYSEN BIOTECH.LNC• South Korea
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA• Brazil
REMEL EUROPE LIMITED• England (United Kingdom)
ENTAMOEBA SP
Entamoeba Histolytica Rapid Test Cassette
HYSEN BIOTECH.LNC
80464810922
Jun 16, 2025
ENTAMOEBA SP
RIDASCREEN® Entamoeba
R-BIOPHARM AG
82890930008
Apr 28, 2025
ENTAMOEBA SP
E. histolytica TF Quicktest
BIO BRASIL CIENCIA E TECNOLOGIA LTDA
81249610020
Jan 15, 2024
ENTAMOEBA SP
Família Cassete de Teste Rápido de Entamoeba histolytica (Fezes)
HANGZHOU ALLTEST BIOTECH CO., LTD
81325990289
Jul 31, 2023
ENTAMOEBA SP
FASTLINE ENTAMOEBA HISTOLYTICA Ag
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220121
Mar 13, 2023