COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III - ANVISA Registration 10158120734
Access comprehensive regulatory information for COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 10158120734 and manufactured by BIOFIRE DIAGNOSTICS LLC. The registration is held by BIOMERIEUX BRASIL INDUSTRIA E COMERCIO DE PRODUTOS LABORATORIAIS LTDA with validity until Aug 16, 2031.
This page provides complete technical specifications for 2 related devices, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including BIO-RAD LABORATORIES INC, RADIOMETER MEDICAL APS, 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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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
10158120734
25351689915202134
33040635000171
Company Information
Dates and Status
Aug 16, 2021
16/08/2031
09/18/2025 19:00:01
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
Cobas ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel
GENMARK DIAGNOSTICS, INC.
10287411670
Aug 14, 2023
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
Cobas ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel
Not specified
10287411670
Aug 14, 2023
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
Cobas ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel
GENMARK DIAGNOSTICS, INC.
10287411669
Aug 14, 2023
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
Cobas ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel
Not specified
10287411669
Aug 14, 2023
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
BIOFIRE FILMARRAY PNEUMONIA PANEL
Not specified
10158120724
Apr 13, 2020
BIO-RAD LABORATORIES INC• United States of America
RADIOMETER MEDICAL APS• Denmark
SEEGENE INC.• South Korea
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA• Brazil
ROCHE DIAGNOSTICS GMBH• Germany
PARÂMETROS COMBINADOS NO MESMO PRODUTO - CLASSE III
Cartucho de Teste-iBG8-OXI
Not specified
80047300904
Sep 15, 2025
PARÂMETROS COMBINADOS NO MESMO PRODUTO - CLASSE III
Cartucho de Teste-iBG8-OXI
EDAN INSTRUMENTS, INC.
80047300904
Sep 15, 2025
PARÂMETROS COMBINADOS NO MESMO PRODUTO - CLASSE III
Cartucho de Teste-iBG8
EDAN INSTRUMENTS, INC.
80047300905
Sep 15, 2025
PARÂMETROS COMBINADOS NO MESMO PRODUTO - CLASSE III
Cartucho de Teste-iBG8
Not specified
80047300905
Sep 15, 2025
PARÂMETROS COMBINADOS NO MESMO PRODUTO - CLASSE III
BIOCLIN POCT FIA CARDÍACO
QUIBASA QUÍMICA BÁSICA LTDA
10269360480
Sep 15, 2025