COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III - ANVISA Registration 80003610586
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 80003610586 and manufactured by INSTRUMENTATION LABORATORY CO.. The registration is held by WERFEN MEDICAL LTDA with validity until Sep 28, 2030.
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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Registration Details
80003610586
25351899723202053
02004662000165
Company Information
Dates and Status
Sep 28, 2020
28/09/2030
09/18/2025 19:00:01
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
GEM Premier ChemSTAT PAK
INSTRUMENTATION LABORATORY CO.
80003610587
Sep 28, 2020
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
GEM Premier ChemSTAT PAK
Not specified
80003610587
Sep 28, 2020
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
GEM Premier 5000 PAK com iQM2
Not specified
80003610542
Dec 26, 2017
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
GEM Premier 5000 PAK com iQM2
INSTRUMENTATION LABORATORY CO.
80003610542
Dec 26, 2017
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
Gem Premier 3500 Pak com IQM
INSTRUMENTATION LABORATORY
80003610272
Jun 23, 2010
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