Instrument intended for immunoassays - ANVISA Registration 10355870325
Access comprehensive regulatory information for Instrument intended for immunoassays in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 10355870325 and manufactured by HIBERGENE DIAGNOSTICS LTD. The registration is held by BIOMÉDICA EQUIPAMENTOS E SUPRIMENTOS HOSPITALARES 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 HANGZHOU ALLTEST BIOTECH CO. LTD, 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.

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Registration Details
10355870325
25351759393201840
01299509000140
Company Information
Dates and Status
Feb 04, 2019
VIGENTE
09/18/2025 19:00:01
Instrument intended for immunoassays
Agility
DYNEX TECNOLOGIES
80686360065
Apr 20, 2015
Instrument intended for immunoassays
PERSONAL LAB
ADALTIS S.R.L.
10300390840
Sep 21, 2020
Instrument intended for immunoassays
PERSONAL LAB
ADALTIS S.R.L.
80345000218
Jan 10, 2011
Instrument intended for immunoassays
BOLT
GOLD STANDARD DIAGNOSTICS
81905510017
Mar 04, 2021
Instrument intended for immunoassays
LABOTECH
ADALTIS
80345000220
Apr 11, 2011
HANGZHOU ALLTEST BIOTECH CO. LTD• China
ACRO BIOTECH, INC. (MONTCLAIR)• United States of America
DIAMED GMBH• Switzerland
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD• China
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