COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III - ANVISA Registration 80105220195
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 80105220195 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 Jun 17, 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 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
Need help with your Brazil registration?
Contact Pure Global Brazil TeamDevice Details
Registration Details
80105220195
25351013418202411
04299232000143
Company Information
Dates and Status
Jun 17, 2024
17/06/2034
09/18/2025 19:00:01
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
FASTLINE H-FABP + TROPONINA I
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220196
Jun 17, 2024
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
FASTLINE FIA TROPONINA I + D-DÍMERO + NT-proBNP
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220256
Feb 10, 2025
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
HUBI FABP – TROPONINA I
HUMASIS CO., LTDA
80615950227
Jul 15, 2019
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
HUBI FABP – TROPONINA I
Not specified
80615950227
Jul 15, 2019
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
Troponina T + CKMB + Mioglobina (FIA)
ZYBIO INC.
82221430028
Jan 16, 2023
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