MEDICA CORPORATION: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
ELETRODO DE SÓDIO 80367750192	Sodium	II	BIOSYSTEMS NE COMÉRCIO DE PRODUTOS LABORATORIAIS E HOSPITALARES LTDA	14/07/2025	Valid
ELETRODO CLORO 80367750193	Chloride	II	BIOSYSTEMS NE COMÉRCIO DE PRODUTOS LABORATORIAIS E HOSPITALARES LTDA	14/07/2025	Valid
ELETRODO DE POTÁSSIO 80367750194	Potassium	II	BIOSYSTEMS NE COMÉRCIO DE PRODUTOS LABORATORIAIS E HOSPITALARES LTDA	14/07/2025	Valid
Diluente de Urina 81692610299	Buffers, diluents and other solutions for laboratory analysis	I	VYTTRA DIAGNOSTICOS S.A.	17/02/2025	Valid
ISE Module 81692610300	Electrolytes	II	VYTTRA DIAGNOSTICOS S.A.	17/02/2025	Valid
ISE Module Reagent Pack 81692610301	Electrolytes	II	VYTTRA DIAGNOSTICOS S.A.	17/02/2025	Valid
Diluente de Urina para Módulo ISE 80367750115	Buffers, diluents and other solutions for laboratory analysis	I	BIOSYSTEMS NE COMÉRCIO DE PRODUTOS LABORATORIAIS E HOSPITALARES LTDA	23/09/2021	Valid
ISE Module Reagent Pack, Na/K/Cl/Li 80115310257	Combined parameters in one product - class III	III	KOVALENT DO BRASIL LTDA	14/10/2019	Until 27/07/2036
EasyLyte Expand Solution Pack 80115310253	Combined parameters in one product - class III	III	KOVALENT DO BRASIL LTDA	01/04/2019	Until 14/09/2036
EasyLyte EXPAND 80115310252	Analyzer for blood gases, ions or pH	II	KOVALENT DO BRASIL LTDA	25/03/2019	Valid
EASYLYTE NA/K - ANALISADOR BIOQUIMICO 80115310229	Analyzer for blood gases, ions or pH	II	KOVALENT DO BRASIL LTDA	05/02/2018	Valid
Solução Corante Vermelha para Teste 80115310228	Buffers, diluents and other solutions for laboratory analysis	I	KOVALENT DO BRASIL LTDA	22/01/2018	Valid
EasyBloodGas 80115310230	Analyzer for general chemistry, hormones, drugs or proteins	II	KOVALENT DO BRASIL LTDA	22/01/2018	Valid
FAMÍLIA EasyQC – Controles de Qualidade para Analisadores de Eletrólitos 80115310231	Combined parameters in one product - class III	III	KOVALENT DO BRASIL LTDA	22/01/2018	Until 08/06/2036
EASYLYTE NA/K/LI - ANALISADOR BIOQUIMICO 80115310232	Analyzer for general chemistry, hormones, drugs or proteins	II	KOVALENT DO BRASIL LTDA	22/01/2018	Valid
ANALISADOR EASYLYTE NA/K/Cl 80115310233	Analyzer for blood gases, ions or pH	II	KOVALENT DO BRASIL LTDA	22/01/2018	Valid
Easy QC Controle de qualidade em Dois Níveis para Hematócrito 80115310234	Blood cell count	II	KOVALENT DO BRASIL LTDA	22/01/2018	Valid
Solução de Preenchimento Interno 80115310236	Buffers, diluents and other solutions for laboratory analysis	I	KOVALENT DO BRASIL LTDA	22/01/2018	Valid
Solução Padrão de Urina 80115310238	Buffers, diluents and other solutions for laboratory analysis	I	KOVALENT DO BRASIL LTDA	22/01/2018	Valid
ANALISADOR EASYSTAT / ACESSORIOS 80115310239	Analyzer for blood gases, ions or pH	II	KOVALENT DO BRASIL LTDA	22/01/2018	Valid
FAMÍLIA EasyQC – Controles de Qualidade de Eletrólitos e Gases Sanguíneos 80115310240	Combined parameters in one product - class III	III	KOVALENT DO BRASIL LTDA	22/01/2018	Until 08/06/2036
Diluente de Urina 80115310241	Buffers, diluents and other solutions for laboratory analysis	I	KOVALENT DO BRASIL LTDA	22/01/2018	Valid
EASYLYTE NA/K/CL/LI 80115310243	Analyzer for blood gases, ions or pH	II	KOVALENT DO BRASIL LTDA	22/01/2018	Valid
EASYLYTE NA/K/CA/PH 80115310244	Analyzer for blood gases, ions or pH	II	KOVALENT DO BRASIL LTDA	22/01/2018	Valid
EasyLyte Calcium – Embalagem de Soluções 80115310245	Combined parameters in one product - class II	II	KOVALENT DO BRASIL LTDA	22/01/2018	Valid
EasyStat Módulo Reagente 80115310246	Combined parameters in one product - class II	II	KOVALENT DO BRASIL LTDA	22/01/2018	Valid
ANALISADOR EASYLYTE Na/K/Ca/pH 80144950483	Analyzer for blood gases, ions or pH	II	REM INDUSTRIA E COMERCIO LTDA	10/11/2014	Valid
EASYLYTE BIOQUÍMICO Na/K/CI/Li 80144950484	Analyzer for blood gases, ions or pH	II	REM INDUSTRIA E COMERCIO LTDA	10/11/2014	Valid
SISTEMAS RAPIDPOINT 300 10345161782	Analyzer for blood gases, ions or pH	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	30/11/2010	Valid

MEDICA CORPORATION

Brazilian registration holders

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Registrations