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ANVISA registration 80885650064Valid until Aug 15, 2032

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

ANVISA Registration Number: 80885650064ORBITAE 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 Assure Autoteste
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Risk class
Class III
Registration details
Registration Number
80885650064
Process Number
25351162299202250
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 15, 2022
Validity
15/08/2032
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 80885650064 and manufactured by ASSURE TECH. (HANGZHOU) CO., LTD.. The registration is held by ORBITAE DIAGNOSTICOS S/A with validity until Aug 15, 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.