MYOGLOBIN - CLASS II - ANVISA Registration 10345161441
Access comprehensive regulatory information for MYOGLOBIN - CLASS II in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 10345161441 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC. The registration is held by SIEMENS HEALTHCARE 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 ROCHE DIAGNOSTICS GMBH, SIEMENS HEALTHCARE DIAGNOSTICS INC., 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
10345161441
25351200002200948
01449930000190
Company Information
Dates and Status
Aug 24, 2009
VIGENTE
09/18/2025 19:00:01
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
CALIBRADOR DE PROTEINA ESPECIAL - DIMENSION
SIEMENS HEALTHCARE DIAGNOSTICS INC
10345161511
Aug 24, 2009
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
CALIBRADOR DE PROTEINAS ESPECIFICAS
RANDOX LABORATORIES LTD.
80158990085
Oct 10, 2005
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
CALIBRADOR DE PROTEÍNA LÍQUIDA DE IMUNOGLOBULINA
RANDOX LABORATORIES LTD.
80158990312
Dec 03, 2018
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
Calibrador de Proteínas Específicas
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
80102511265
Jul 07, 2014
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
Calibradores de proteínas
BIOSYSTEMS S.A.
80367750155
Nov 07, 2022
ROCHE DIAGNOSTICS GMBH• Germany
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.• China
ABBOTT IRELAND DIAGNOSTICS DIVISION• Ireland
ABBOTT IRELAND DIAGNOSTIC DIVISION• Ireland
MIOGLOBINA - CLASSE II
Mioglobina (Imunoensaio de Eletroquimioluminescência)
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
80102512844
Jul 07, 2022
MIOGLOBINA - CLASSE II
Mioglobina STAT (MYO STAT) eCLIA
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
80102512849
Jul 07, 2022
MIOGLOBINA - CLASSE II
Família SuperFlex Myoglobin
SUZHOU SYM-BIO LIFESCIENCE CO., LTD
10298910164
Aug 05, 2021
MIOGLOBINA - CLASSE II
Mioglobina
IN VITRO DIAGNOSTICA LTDA
10303460512
Aug 05, 2021
MIOGLOBINA - CLASSE II
RAMP® Mioglobina
RESPONSE BIOMEDICAL CORP.
80102512660
May 20, 2021