TROPONIN - ANVISA Registration 80105220186
Access comprehensive regulatory information for TROPONIN in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 80105220186 and manufactured by KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA. The registration is held by KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA with validity until Apr 15, 2034.
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, BODITECH MED 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.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Registration Details
80105220186
25351894592202441
04299232000143
Company Information
Dates and Status
Apr 15, 2024
15/04/2034
09/18/2025 19:00:01
TROPONIN
FASTLINE FIA TROPONINA I
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220229
Oct 21, 2024
TROPONIN
FASTLINE FIA TROPONINA T
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220244
Dec 30, 2024
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
FASTLINE H-FABP + MIOGLOBINA + CKMB + TROPONINA I
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220195
Jun 17, 2024
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
FASTLINE MIOGLOBINA + CKMB + TROPONINA I
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220200
Jun 17, 2024
TROPONIN
BIOCLIN FAST TROPONINA I
QUIBASA QUÍMICA BÁSICA LTDA
10269360436
Sep 18, 2023
TROPONINA
BIOCLIN POCT FIA TROPONINA I
QUIBASA QUÍMICA BÁSICA LTDA
10269360479
Sep 15, 2025
TROPONINA
Luminis FIA Troponina I
Not specified
80474870163
Sep 08, 2025
TROPONINA
Luminis FIA Troponina I
QINGDAO HIGHTOP BIOTECH CO.,LTD.
80474870163
Sep 08, 2025
TROPONINA
BIOCLIN POCT FIA TROPONINA I-US
QUIBASA QUÍMICA BÁSICA LTDA
10269360475
Aug 04, 2025
TROPONINA
FIA Troponina HS
GOLD ANALISA DIAGNOSTICA LTDA
80022230297
Jul 14, 2025