CA 15-3 ANTIGEN - ANVISA Registration 80943610097
Access comprehensive regulatory information for CA 15-3 ANTIGEN in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 80943610097 and manufactured by SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. The registration is held by MINDRAY DO BRASIL COMÉRCIO E DISTRIBUIÇÃO DE EQUIPAMENTOS MÉDICOS LTDA. with validity until May 28, 2028.
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 ABBOTT GMBH, 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
80943610097
25351348167202051
09058456000187
Company Information
Dates and Status
Jun 01, 2020
28/05/2028
09/18/2025 19:00:01
CA 15-3 ANTIGEN
FAMÍLIA MAGLUMI CA 15-3 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102512876
Sep 19, 2022
CA 15-3 ANTIGEN
FAMÍLIA MAGLUMI CA 15-3 (CLIA)
Not specified
80102512876
Sep 19, 2022
CA 15-3 ANTIGEN
Família Atellica IM CA 15-3 (CA 15-3)
Not specified
10345162242
Apr 30, 2018
CA 15-3 ANTIGEN
Família Atellica IM CA 15-3 (CA 15-3)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
10345162242
Apr 30, 2018
CA 15-3 ANTIGEN
Família AutoLumo Micropartículas de CA15-3 (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513428
May 19, 2025
ANTÍGENO CA 15-3
Família AutoLumo Micropartículas de CA15-3 (CLIA)
Not specified
80102513428
May 19, 2025
ANTÍGENO CA 15-3
Família AutoLumo Micropartículas de CA15-3 (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513428
May 19, 2025
ANTÍGENO CA 15-3
CA 15-3 Reagent Kit
LABTEST DIAGNOSTICA S/A
10009010473
Oct 21, 2024
ANTÍGENO CA 15-3
Família VITROS Immunodiagnostic Products CA 15-3 Reagent Pack and Calibrator
Not specified
81246986895
Jun 17, 2024
ANTÍGENO CA 15-3
Família VITROS Immunodiagnostic Products CA 15-3 Reagent Pack and Calibrator
ORTHO CLINICAL DIAGNOSTICS
81246986895
Jun 17, 2024