SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS) - ANVISA Registration 80115310272
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 80115310272 and manufactured by KOVALENT DO BRASIL LTDA. The registration is held by KOVALENT DO BRASIL LTDA with validity until Feb 25, 2032.
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 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
80115310272
25351051661202268
04842199000156
Company Information
Dates and Status
Feb 25, 2022
25/02/2032
09/18/2025 19:00:01
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)
AUTOTESTE 2019-nCoV
GUANGZHOU WONDFO BIOTECH CO., LTD
80258020133
May 02, 2022
SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS)
AUTOTESTE 2019-nCoV
Not specified
80258020133
May 02, 2022
SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS)
Autoteste COVID-19
KATAL BIOTECNOLOGICA INDÚSTRIA E COMÉRCIO LTDA
10377390248
Aug 08, 2022
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