ALPHAFETOPROTEIN (AFP) - ANVISA Registration 10158120125
Access comprehensive regulatory information for ALPHAFETOPROTEIN (AFP) in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 10158120125 and manufactured by BIOMERIEUX SA. The registration is held by BIOMERIEUX BRASIL INDUSTRIA E COMERCIO DE PRODUTOS LABORATORIAIS LTDA with validity until May 17, 2026.
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 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD., ROCHE DIAGNOSTICS GMBH, 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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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
10158120125
250000186259548
33040635000171
Company Information
Dates and Status
May 17, 1996
17/05/2026
09/18/2025 19:00:01
ALPHAFETOPROTEIN (AFP)
VIDAFIATeste AFP
Vida Biotecnologia Ltda - ME
80785070139
Sep 27, 2021
ALPHAFETOPROTEIN (AFP)
FASTLINE AFP
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220218
Sep 16, 2024
ALPHAFETOPROTEIN (AFP)
FASTLINE FIA AFP
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220264
Mar 31, 2025
ALPHAFETOPROTEIN (AFP)
Elecsys AFP
ROCHE DIAGBOSTICS GMBH
10287411263
Sep 11, 2017
ALPHAFETOPROTEIN (AFP)
Elecsys AFP
Not specified
10287411263
Sep 11, 2017
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.• United Kingdom
ROCHE DIAGNOSTICS GMBH• Germany
WALLAC OY• Finland
ABBOTT IRELAND DIAGNOSTIC DIVISION• Ireland
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA• Brazil
ALFAFETOPROTEÍNA (AFP)
Família AutoLumo Micropartículas de P-AFP (CLIA)
Not specified
80102513441
Jun 09, 2025
ALFAFETOPROTEÍNA (AFP)
Família AutoLumo Micropartículas de P-AFP (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513441
Jun 09, 2025
ALFAFETOPROTEÍNA (AFP)
Familia AutoLumo AFP Micropartículas (CLIA)
Not specified
80102513415
Apr 22, 2025
ALFAFETOPROTEÍNA (AFP)
Familia AutoLumo AFP Micropartículas (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513415
Apr 22, 2025
ALFAFETOPROTEÍNA (AFP)
FASTLINE FIA AFP
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220264
Mar 31, 2025