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ANVISA registration 80885650065Valid until Aug 22, 2032

SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS)

ANVISA Registration Number: 80885650065ORBITAE DIAGNOSTICOS S/AASSURE TECH. (HANGZHOU) CO., LTD.Risk Class III
Verified
Device names
Technical name
SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS)
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PT: AUTOTESTE PARA ANTÍGENO DO SARS-COV-2 (CORONAVÍRUS)
Commercial name
FaStep Covid-19 Ag II Assure Autoteste
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Risk class
Class III
Registration details
Registration Number
80885650065
Process Number
25351223921202211
CNPJ
11162384000165
Company information
Registration Holder
ORBITAE DIAGNOSTICOS S/A
Manufacturer
ASSURE TECH. (HANGZHOU) CO., LTD.
Manufacturing Country
China
PT: CHINA, REPÚBLICA POPULAR
Dates and status
Publication Date
Aug 22, 2022
Validity
22/08/2032
Last Updated
08/18/2026 19:00:00
About this record

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 80885650065 and manufactured by ASSURE TECH. (HANGZHOU) CO., LTD.. The registration is held by ORBITAE DIAGNOSTICOS S/A with validity until Aug 22, 2032.

This page shows the facts attached to this official registry row. Exact-name links return deterministic registry matches; open-ended comparison and market analysis are handed to AI Search with this record's context, without asserting that similar names represent the same entity.