MYOGLOBIN - CLASS II - ANVISA Registration 80537410065
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 80537410065 and manufactured by GUANGZHOU WONDFO BIOTECH CO., LTD.. The registration is held by CELER BIOTECNOLOGIA S/A 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
80537410065
25351640944202017
04846613000103
Company Information
Dates and Status
Aug 31, 2020
VIGENTE
09/18/2025 19:00:01
MYOGLOBIN - CLASS II
Mioglobina STAT (MYO STAT) eCLIA
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
80102512849
Jul 07, 2022
MYOGLOBIN - CLASS II
Mioglobina (Imunoensaio de EletroquimioluminescĂŞncia)
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
80102512844
Jul 07, 2022
MYOGLOBIN
FASTLINE MIOGLOBINA
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220187
Apr 15, 2024
MYOGLOBIN
Luminis FIA Mioglobina
Not specified
80474870167
Sep 08, 2025
MYOGLOBIN
Luminis FIA Mioglobina
QINGDAO HIGHTOP BIOTECH CO.,LTD.
80474870167
Sep 08, 2025
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 EletroquimioluminescĂŞncia)
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
FamĂlia 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