CORONAVIRUS - ANVISA Registration 80115310266
Access comprehensive regulatory information for CORONAVIRUS in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 80115310266 and manufactured by SUGENTECH, INC.. The registration is held by KOVALENT DO BRASIL LTDA with validity until Nov 03, 2030.
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 GUANGZHOU WONDFO BIOTECH CO., LTD., Eco Diagnostica 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.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
80115310266
25351046621202032
04842199000156
Company Information
Dates and Status
Nov 03, 2020
03/11/2030
09/18/2025 19:00:01
CORONAVIRUS
SGTi-flex COVID-19 IgM/IgG
Not specified
80115310262
Aug 03, 2020
CORONAVIRUS
SGTi-flex COVID-19 IgM/IgG
SUGENTECH INC
80115310262
Aug 03, 2020
SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS)
SGTi-flex COVID-19 Ag – SELF TEST
Not specified
80115310273
Mar 02, 2022
SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS)
SGTi-flex COVID-19 Ag – SELF TEST
SUGENTECH, INC.
80115310273
Mar 02, 2022
SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS)
SGTi-flex COVID-19 Ag – AUTOTESTE
KOVALENT DO BRASIL LTDA
80115310272
Feb 25, 2022
CORONAVÍRUS
Kit Rápido de Detecção de Antígeno de SARS-CoV-2 (COVID-19)
JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD.
82444370255
Sep 01, 2025
CORONAVÍRUS
Kit Rápido de Detecção de Antígeno de SARS-CoV-2 (COVID-19)
Not specified
82444370255
Sep 01, 2025
CORONAVÍRUS
Teste Rápido COVID-19
Not specified
81472060050
Aug 25, 2025
CORONAVÍRUS
Teste Rápido COVID-19
HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD.
81472060050
Aug 25, 2025
CORONAVÍRUS
Xpert Xpress CoV-2 plus
Not specified
81062710058
Aug 18, 2025