CALPROTECTIN - ANVISA Registration 10355870392
Access comprehensive regulatory information for CALPROTECTIN in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 10355870392 and manufactured by CERTEST BIOTEC S.L.. The registration is held by BIOMÉDICA EQUIPAMENTOS E SUPRIMENTOS HOSPITALARES 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 PHADIA AB, Nanosens Ltda, 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
10355870392
25351186615202017
01299509000140
Company Information
Dates and Status
Oct 22, 2020
VIGENTE
09/18/2025 19:00:01
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
FASTLINE CALPROTECTINA E LACTOFERRINA
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220144
Jul 24, 2023
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
FASTLINE CALPROTECTINA + SANGUE OCULTO
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220198
Jun 17, 2024
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
FAMÍLIA CALIBRADORES DE IMUNOTURBIDIMETRIA
GT LABORATORIOS SRL
80538800009
Jun 01, 2015
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
EUROLINE: Doenças gastrointestinais autoimunes IgA
EUROIMMUN AG
10338930232
Jul 06, 2020
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
Control Inmunologico nível 2 Turbitest AA
LABORLAB PRODUTOS PARA LABORATÓRIOS LTDA EPP
10246810178
Mar 09, 2015
CALPROTECTINA
Calprotectin Quality Control (Quantitative)
ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.
81778810046
Sep 15, 2025
CALPROTECTINA
Família AFIAS Calprotectin
BODITECH MED INC.
10350840486
Sep 01, 2025
CALPROTECTINA
Família CALiaGold Sentinel
SENTINEL CH.SPA
80856940008
Apr 07, 2025
CALPROTECTINA
RIDASCREEN® Calprotectin
R-BIOPHARM AG
82890930006
Mar 05, 2025
CALPROTECTINA
FAMÍLIA DIAZYME CALPROTECTIN ASSAY
DIAZYME LABORATORIES, INC.
82444370205
Mar 05, 2025