Balloon - ANVISA Registration 80588399001
Access comprehensive regulatory information for Balloon in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80588399001 and manufactured by ESTABLISHMENT LABS S.A. (BUILDING B15). The registration is held by ESTABLISHMENT LABS BRASIL PRODUTOS PARA SAUDE LTDA with validity until currently active (VIGENTE).
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 SCITECH PRODUTOS MEDICOS SA, Xiamen Compower Medical Tech. CO., Ltd., 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
80588399001
25351457946202128
08290164000102
Company Information
Dates and Status
May 20, 2021
VIGENTE
09/18/2025 19:00:01
Balloon
Balão Expansível para Tecidos Moles
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81000039020
Apr 22, 2024
Balloon
BALÃO PARA CIFOPLASTIA
Dragon Crown Medical Co., Ltd
81271570004
Jun 13, 2016
Balloon Inflation and Pressure Gauge
INSUFLADOR PARA CATETER
Jiuhong
80320689002
Dec 08, 2014
Balloon
balão de silicone sillmed
SILLMED INDUSTRIA E COMÉRCIO DE PRODUTOS EM SILICONE LTDA
81861770004
Apr 27, 2020
Catheter Inflator
Dispositivo para Insuflação de Balões
BRUN MEDICAL CO., LTD
81778810029
Sep 23, 2024
SCITECH PRODUTOS MEDICOS SA• Brazil
Xiamen Compower Medical Tech. CO., Ltd.• China
BHIO SUPPLY INDUSTRIA E COMERCIO DE EQUIPAMENTOS MEDICOS S/A• Brazil
PROTEC EXPORT INDÚSTRIA, COMÉRCIO, IMPORTAÇAO E EXPORTAÇÃO DE EQUIPAMENTOS MÉDICOS HOSPITALARES LTDA• Brazil
Osseon Therapeutics,Inc• United States of America
Balao
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MEDICONE PROJETOS E SOLUÇÕES PARA A INDÚSTRIA E A SAÚDE LTDA
80020559013
Aug 04, 2025
Balao
Balão de dilatação gradual
PROMEDON DO BRASIL PRODUTOS MEDICO HOSPITALARES LTDA
83108319004
Apr 07, 2025
Balao
Balão de dilatação monoestágio
PROMEDON DO BRASIL PRODUTOS MEDICO HOSPITALARES LTDA
83108319013
Apr 07, 2025
Balao
BALÃO RESPIRATÓRIO LATEX FREE SILLMED
SILLMED INDUSTRIA E COMÉRCIO DE PRODUTOS EM SILICONE LTDA
81861770010
Feb 24, 2025
Balao
Cateteres de dilatação com balão de uso único
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
81504799178
Feb 24, 2025