SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS) - ANVISA Registration 80115310273
Access comprehensive regulatory information for SELF-TEST FOR SARS-COV-2 ANTIGEN (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 80115310273 and manufactured by SUGENTECH, INC.. The registration is held by KOVALENT DO BRASIL LTDA with validity until Mar 02, 2032.
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 HANGZHOU ALLTEST BIOTECH CO. LTD, GENRUI BIOTECH INC., 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
80115310273
25351051652202277
04842199000156
Company Information
Dates and Status
Mar 02, 2022
02/03/2032
09/18/2025 19:00:01
SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS)
SGTi-flex COVID-19 Ag – AUTOTESTE
KOVALENT DO BRASIL LTDA
80115310272
Feb 25, 2022
SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS)
HOME TEST COVID-19 AG
Not specified
80638720211
Apr 04, 2022
SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS)
HOME TEST COVID-19 AG
GUANGZHOU WONDFO BIOTECH CO., LTD
80638720211
Apr 04, 2022
SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS)
Covid Ag - Home Test
GOLD ANALISA DIAGNOSTICA LTDA
80022230249
Aug 08, 2022
CORONAVIRUS
SGTi-flex COVID-19 Ag
SUGENTECH, INC.
80115310266
Nov 03, 2020
AUTOTESTE PARA ANTÍGENO DO SARS-COV-2 (CORONAVÍRUS)
VivaDiag Pro SARS-CoV-2 Ag Rapid Test - AUTOTESTE
VIVACHEK BIOTECH (HANGZHOU) CO., LTD.
82286660013
Sep 01, 2025
AUTOTESTE PARA ANTÍGENO DO SARS-COV-2 (CORONAVÍRUS)
VivaDiag Pro SARS-CoV-2 Ag Rapid Test - AUTOTESTE
Not specified
82286660013
Sep 01, 2025
AUTOTESTE PARA ANTÍGENO DO SARS-COV-2 (CORONAVÍRUS)
COVID-19 (SARS-CoV-2) Antigen Self-Test Kit
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD.
82444370196
Feb 17, 2025
AUTOTESTE PARA ANTÍGENO DO SARS-COV-2 (CORONAVÍRUS)
COVID-19 (SARS-CoV-2) Antigen Self-Test Kit
Not specified
82444370196
Feb 17, 2025
AUTOTESTE PARA ANTÍGENO DO SARS-COV-2 (CORONAVÍRUS)
DETECTA COVID PLUS
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220235
Dec 02, 2024