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Dispositivos MédicosAtivo

APARELHO AUDITIVO INTRAARICULAR ENCHANT

10356029020
Informações Gerais

Nome do produto

APARELHO AUDITIVO INTRAARICULAR ENCHANT

Número de registro

10356029020

Nome técnico

Aparelho Auditivo

Classe de risco

II

Processo

25351055074202248

Empresa Detentora

Razão social

CENTRO AUDITIVO TELEX LTDA

CNPJ

33.060.302/0001-04

Fabricante

SONIC INNOVATION, INC

País de fabricação

ESTADOS UNIDOS DA AMÉRICA

Registro

Situação

Ativo

Vencimento

Registro vigente

Validade prevista: 10/02/2027

Histórico de Situação
VálidoATIVO07/05/2026

Detectado a cada sincronização diária com a ANVISA.

Apresentações / Modelos(219)

  • ET20

    IIC (Enchant 20) –192128 ET20, KIT IIC 10 85 BL ENCHANT 20

  • ET20

    CIC (Enchant 20) – 192122 ET20, KIT 10 NFM 85 BE ENCHANT 20

  • ET20

    ITC (Enchant 20) – 192161 ET20, KIT 312 NFM PB T L BE ENCHANT 20

  • ET40

    IIC (Enchant 40) - 192079 ET40, KIT IIC 10 75 BL ENCHANT 40

  • ET40

    ITC (Enchant 40) – 192090 ET40, KIT 312 2.4G NFM 90 R BE ENCHANT 40

  • ET60

    CIC (Enchant 60)- 186274 ET60, KIT 10 75 BE ENCHANT 60

  • ET60

    ITC (Enchant 60) – 186280 ET60, KIT 312 2.4G NFM 75 R BE ENCHANT 60

  • ET60

    IIC (Enchant 60) – 186275 ET60, KIT IIC 10 75 BL ENCHANT 60

  • ET80

    ITC (Enchant 80) – 186228 ET80, KIT 312 2.4G NFM 75 R BE ENCHANT 80

  • ET80

    CIC (Enchant 80)- 186216 ET80, KIT 10 NFM 75 BE ENCHANT 80

  • ET100

    IIC (Enchant 100) -186158 ET100, KIT IIC 10 75 BL ENCHANT 100

  • ET100

    ITC (Enchant 100) – 186163 ET100, KIT 312 2.4G NFM 75 R BE ENCHANT 100

  • 186153 ET100, KIT 10 NFM 75 PB BE ENCHANT 100

  • 186154 ET100, KIT 10 NFM 85 BE ENCHANT 100

  • 186156 ET100, KIT 10 NFM 85 PB BE ENCHANT 100

  • 186157 ET100, KIT 10 75 BE ENCHANT 100

  • 186159 ET100, KIT 10 75 PB BE ENCHANT 100

  • 186160 ET100, KIT 10 85 BE ENCHANT 100

  • 186161 ET100, KIT IIC 10 85 BL ENCHANT 100ET80 IIC (Enchant 80) - 186223 ET80, KIT IIC 10 75 BL ENCHANT 80

  • 186162 ET100, KIT 10 85 PB BE ENCHANT 100

  • 186164 ET100, KIT 312 2.4G NFM 75 L BE ENCHANT 100

  • 186167 ET100, KIT 312 2.4G NFM 85 PB R BE ENCHANT 100

  • 186168 ET100, KIT 312 2.4G NFM 85 PB L BE ENCHANT 100

  • 186171 ET100, KIT 312 2.4G NFM 90 R BE ENCHANT 100

  • 186172 ET100, KIT 312 2.4G NFM 90 L BE ENCHANT 100

  • 186173 ET100, KIT 312 2.4G NFM 90 PB R BE ENCHANT 100

  • 186174 ET100, KIT 312 2.4G NFM 90 PB L BE ENCHANT 100

  • 186175 ET100, KIT 312 2.4G NFM R BE ENCHANT 100

  • 186176 ET100, KIT 312 2.4G NFM L BE ENCHANT 100

  • 186177 ET100, KIT 312 2.4G NFM PB R BE ENCHANT 100

  • 186178 ET100, KIT 312 2.4G NFM PB L BE ENCHANT 100

  • 186181 ET100, KIT 312 NFM 75 R BE ENCHANT 100

  • 186182 ET100, KIT 312 NFM 75 L BE ENCHANT 100

  • 186183 ET100, KIT 312 NFM 85 R BE ENCHANT 100

  • 186184 ET100, KIT 312 NFM 85 L BE ENCHANT 100

  • 186185 ET100, KIT 312 NFM 85 PB R BE ENCHANT 100

  • 186186 ET100, KIT 312 NFM 85 PB L BE ENCHANT 100

  • 186187 ET100, KIT 312 NFM 85 PB T R BE ENCHANT 100

  • 186188 ET100, KIT 312 NFM 85 PB T L BE ENCHANT 100

  • 186189 ET100, KIT 312 NFM 90 R BE ENCHANT 100

  • 186190 ET100, KIT 312 NFM 90 L BE ENCHANT 100

  • 186191 ET100, KIT 312 NFM 90 PB R BE ENCHANT 100

  • 186192 ET100, KIT 312 NFM 90 PB L BE ENCHANT 100

  • 186193 ET100, KIT 312 NFM R BE ENCHANT 100

  • 186194 ET100, KIT 312 NFM L BE ENCHANT 100

  • 186195 ET100, KIT 312 NFM PB R BE ENCHANT 100

  • 186196 ET100, KIT 312 NFM PB L BE ENCHANT 100

  • 186197 ET100, KIT 312 NFM PB T R BE ENCHANT 100

  • 186198 ET100, KIT 312 NFM PB T L BE ENCHANT 100

  • 186218 ET80, KIT 10 NFM 75 PB BE ENCHANT 80

  • 186219 ET80, KIT 10 NFM 85 BE ENCHANT 80

  • 186221ET80, KIT 10 NFM 85 PB BE ENCHANT 80

  • 186222 ET80, KIT 10 75 BE ENCHANT 80

  • 186224

  • 186225 ET80, KIT 10 85 BE ENCHANT 80

  • 186226 ET80, KIT IIC 10 85 BL ENCHANT 80

  • 186227 ET80, KIT 10 85 PB BE ENCHANT 80

  • 186229 ET80, KIT 312 2.4G NFM 75 L BE ENCHANT 80

  • 186231 ET80, KIT 312 2.4G NFM 85 L BE ENCHANT 80

  • 186232 ET80, KIT 312 2.4G NFM 85 PB R BE ENCHANT 80

  • 186233 ET80, KIT 312 2.4G NFM 85 PB L BE ENCHANT 80

  • 186236 ET80, KIT 312 2.4G NFM 90 R BE ENCHANT 80

  • 186237 ET80, KIT 312 2.4G NFM 90 R BE ENCHANT 80

  • 186238 ET80, KIT 312 2.4G NFM 90 R BE ENCHANT 80

  • 186239 ET80, KIT 312 2.4G NFM 90 R BE ENCHANT 80

  • 186240 ET80, KIT 312 2.4G NFM R BE ENCHANT 80

  • 186241 ET80, KIT 312 2.4G NFM L BE ENCHANT 80

  • 186242 ET80, KIT 312 2.4G NFM PB R BE ENCHANT 80

  • 186243 ET80, KIT 312 2.4G NFM PB L BE ENCHANT 80

  • 186246 ET80, KIT 312 NFM 75 R BE ENCHANT 80

  • 186247 ET80, KIT 312 NFM 75 L BE ENCHANT 80

  • 186248 ET80, KIT 312 NFM 85 R BE ENCHANT 80

  • 186249 ET80, KIT 312 NFM 85 L BE ENCHANT 80

  • 186250 ET80, KIT 312 NFM 85 PB R BE ENCHANT 80

  • 186251ET80, KIT 312 NFM 85 PB L BE ENCHANT 80

  • 186252 ET80, KIT 312 NFM 85 PB T R BE ENCHANT 80

  • 186253 ET80, KIT 312 NFM 85 PB T L BE ENCHANT 80

  • 186254 ET80, KIT 312 NFM 90 R BE ENCHANT 80

  • 186255 ET80, KIT 312 NFM 90 L BE ENCHANT 80

  • 186256 ET80, KIT 312 NFM 90 PB R BE ENCHANT 80

  • 186257 ET80, KIT 312 NFM 90 PB L BE ENCHANT 80

  • 186258 ET80, KIT 312 NFM R BE ENCHANT 80 186259 ET80, KIT 312 NFM L BE ENCHANT 80

  • 186260 ET80, KIT 312 NFM PB R BE ENCHANT 80

  • 186261 ET80, KIT 312 NFM PB L BE ENCHANT 80

  • 186262 ET80, KIT 312 NFM PB T R BE ENCHANT 80

  • 186263 ET80, KIT 312 NFM PB T L BE ENCHANT 80

  • 186268 ET60, KIT 10 NFM 75 BE ENCHANT 60

  • 186270 ET60, KIT 10 NFM 75 PB BE ENCHANT 60

  • 186271 ET60, KIT 10 NFM 85 BE ENCHANT 60

  • 186273 ET60, KIT 10 NFM 85 PB BE ENCHANT 60

  • 186276 ET60, KIT 10 75 PB BE ENCHANT 60

  • 186277 ET60, KIT 10 85 BE ENCHANT 60

  • 186278 ET60, KIT IIC 10 85 BL ENCHANT 60

  • 186279 ET60, KIT 10 85 PB BE ENCHANT 60ET40 CIC (Enchant 40) –192078 ET40, KIT 10 75 BE ENCHANT 40

  • 186281 ET60, KIT 312 2.4G NFM 75 L BE ENCHANT 60

  • 186283 ET60, KIT 312 2.4G NFM 85 L BE ENCHANT 60

  • 186284 ET60, KIT 312 2.4G NFM 85 PB R BE ENCHANT 60

  • 186285ET60, KIT 312 2.4G NFM 85 PB L BE ENCHANT 60

  • 186288 ET60, KIT 312 2.4G NFM 90 R BE ENCHANT 60

  • 186289 ET60, KIT 312 2.4G NFM 90 L BE ENCHANT 60

  • 186290 ET60, KIT 312 2.4G NFM 90 PB R BE ENCHANT 60

  • 186291 ET60, KIT 312 2.4G NFM 90 PB L BE ENCHANT 60

  • 186292 ET60, KIT 312 2.4G NFM R BE ENCHANT 60

  • 186293 ET60, KIT 312 2.4G NFM L BE ENCHANT 60

  • 186294 ET60, KIT 312 2.4G NFM PB R BE ENCHANT 60

  • 186295 ET60, KIT 312 2.4G NFM PB L BE ENCHANT 60

  • 186298 ET60, KIT 312 NFM 75 R BE ENCHANT 60

  • 186299 ET60, KIT 312 NFM 75 L BE ENCHANT 60

  • 186300 ET60, KIT 312 NFM 85 R BE ENCHANT 60

  • 186301 ET60, KIT 312 NFM 85 L BE ENCHANT 60

  • 186302 ET60, KIT 312 NFM 85 PB R BE ENCHANT 60

  • 186303 ET60, KIT 312 NFM 85 PB L BE ENCHANT 60

  • 186304 ET60, KIT 312 NFM 85 PB T R BE ENCHANT 60

  • 186305 ET60, KIT 312 NFM 85 PB T L BE ENCHANT 60

  • 186306 ET60, KIT 312 NFM 90 R BE ENCHANT 60

  • 186307 ET60, KIT 312 NFM 90 L BE ENCHANT 60

  • 186308 ET60, KIT 312 NFM 90 PB R BE ENCHANT 60

  • 186309 ET60, KIT 312 NFM 90 PB L BE ENCHANT 60

  • 186310 ET60, KIT 312 NFM R BE ENCHANT 60

  • 186311 ET60, KIT 312 NFM L BE ENCHANT 60

  • 186312 ET60, KIT 312 NFM PB R BE ENCHANT 60

  • 186313 ET60, KIT 312 NFM PB L BE ENCHANT 60

  • 186314 ET60, KIT 312 NFM PB T R BE ENCHANT 60

  • 186315 ET60, KIT 312 NFM PB T L BE ENCHANT 60

  • 192074 ET40, KIT 10 NFM 75 BE ENCHANT 40

  • 192075 ET40, KIT 10 NFM 75 PB BE ENCHANT 40

  • 192076 ET40, KIT 10 NFM 85 BE ENCHANT 40

  • 192077 ET40, KIT 10 NFM 85 PB BE ENCHANT 40

  • 192080 ET40, KIT 10 75 PB BE ENCHANT 40

  • 192081 ET40, KIT 10 85 BE ENCHANT 40

  • 192082 ET40, KIT IIC 10 85 BL ENCHANT 40

  • 192083 ET40, KIT 10 85 PB BE ENCHANT 40

  • 192084 ET40, KIT 312 2.4G NFM 75 R BE ENCHANT 40

  • 192085 ET40, KIT 312 2.4G NFM 75 L BE ENCHANT 40

  • 192087 ET40, KIT 312 2.4G NFM 85 L BE ENCHANT 40

  • 192088 ET40, KIT 312 2.4G NFM 85 PB R BE ENCHANT 40

  • 192089 ET40, KIT 312 2.4G NFM 85 PB L BE ENCHANT 40

  • 192091 ET40, KIT 312 2.4G NFM 90 L BE ENCHANT 40

  • 192092 ET40, KIT 312 2.4G NFM 90 PB R BE ENCHANT 40

  • 192093 ET40, KIT 312 2.4G NFM 90 PB L BE ENCHANT 40

  • 192094 ET40, KIT 312 2.4G NFM R BE ENCHANT 40

  • 192095 ET40, KIT 312 2.4G NFM L BE ENCHANT 40

  • 192096 ET40, KIT 312 2.4G NFM PB R BE ENCHANT 40

  • 192097 ET40, KIT 312 2.4G NFM PB L BE ENCHANT 40

  • 192098 ET40, KIT 312 NFM 75 R BE ENCHANT 40

  • 192099 ET40, KIT 312 NFM 75 L BE ENCHANT 40

  • 192100 ET40, KIT 312 NFM 85 R BE ENCHANT 40

  • 192101 ET40, KIT 312 NFM 85 L BE ENCHANT 40

  • 192102 ET40, KIT 312 NFM 85 PB R BE ENCHANT 40

  • 192103 ET40, KIT 312 NFM 85 PB L BE ENCHANT 40

  • 192104 ET40, KIT 312 NFM 85 PB T R BE ENCHANT 40

  • 192105 ET40, KIT 312 NFM 85 PB T L BE ENCHANT 40

  • 192106 ET40, KIT 312 NFM 90 R BE ENCHANT 40

  • 192107 ET40, KIT 312 NFM 90 L BE ENCHANT 40

  • 192108 ET40, KIT 312 NFM 90 PB R BE ENCHANT 40

  • 192109 ET40, KIT 312 NFM 90 PB L BE ENCHANT 40

  • 192110 ET40, KIT 312 NFM R BE ENCHANT 40

  • 192111ET40, KIT 312 NFM L BE ENCHANT 40

  • 192112 ET40, KIT 312 NFM PB R BE ENCHANT 40

  • 192113 ET40, KIT 312 NFM PB L BE ENCHANT 40

  • 192114 ET40, KIT 312 NFM PB T R BE ENCHANT 40

  • 192115 ET40, KIT 312 NFM PB T L BE ENCHANT 40

  • 192116 ET40, KIT 13 2.4G NFM R BE ENCHANT 40

  • 192117 ET40, KIT 13 2.4G NFM L BE ENCHANT 40

  • 192118 ET40, KIT 13 NFM R BE ENCHANT 40

  • 192119ET40, KIT 13 NFM L BE ENCHANT 40

  • 192120 ET20, KIT 10 NFM 75 BE ENCHANT 20

  • 192121 ET20, KIT 10 NFM 75 PB BE ENCHANT 20

  • 192123 ET20, KIT 10 NFM 85 PB BE ENCHANT 20

  • 192124 ET20, KIT 10 75 BE ENCHANT 20

  • 192125 ET20, KIT IIC 10 75 BL ENCHANT 20

  • 192126 ET20, KIT 10 75 PB BE ENCHANT 20

  • 192127 ET20, KIT 10 85 BE ENCHANT 20

  • 192129 ET20, KIT 10 85 PB BE ENCHANT 20

  • 192131 ET20, KIT 312 2.4G NFM 75 L BE ENCHANT 20

  • 192133 ET20, KIT 312 2.4G NFM 85 L BE ENCHANT 20

  • 192134 ET20, KIT 312 2.4G NFM 85 PB R BE ENCHANT 20

  • 192135ET20, KIT 312 2.4G NFM 85 PB L BE ENCHANT 20

  • 192136 ET20, KIT 312 2.4G NFM 90 R BE ENCHANT 20

  • 192137 ET20, KIT 312 2.4G NFM 90 L BE ENCHANT 20

  • 192138 ET20, KIT 312 2.4G NFM 90 PB R BE ENCHANT 20

  • 192139 ET20, KIT 312 2.4G NFM 90 PB L BE ENCHANT 20

  • 192140 ET20, KIT 312 2.4G NFM R BE ENCHANT 20

  • 192141 ET20, KIT 312 2.4G NFM L BE ENCHANT 20

  • 192142 ET20, KIT 312 2.4G NFM PB R BE ENCHANT 20

  • 192143 ET20, KIT 312 2.4G NFM PB L BE ENCHANT 20

  • 192144 ET20, KIT 312 NFM 75 R BE ENCHANT 20

  • 192145 ET20, KIT 312 NFM 75 L BE ENCHANT 20

  • 192146 ET20, KIT 312 NFM 85 R BE ENCHANT 20

  • 192147 ET20, KIT 312 NFM 85 L BE ENCHANT 20

  • 192148 ET20, KIT 312 NFM 85 PB R BE ENCHANT 20

  • 192149 ET20, KIT 312 NFM 85 PB L BE ENCHANT 20

  • 192150 ET20, KIT 312 NFM 85 PB T R BE ENCHANT 20

  • 192151 ET20, KIT 312 NFM 85 PB T L BE ENCHANT 20

  • 192152 ET20, KIT 312 NFM 90 R BE ENCHANT 20

  • 192153 ET20, KIT 312 NFM 90 L BE ENCHANT 20

  • 192154 ET20, KIT 312 NFM 90 PB R BE ENCHANT 20

  • 192155 ET20, KIT 312 NFM 90 PB L BE ENCHANT 20

  • 192156 ET20, KIT 312 NFM R BE ENCHANT 20

  • 192157 ET20, KIT 312 NFM L BE ENCHANT 20

  • 192158 ET20, KIT 312 NFM PB R BE ENCHANT 20

  • 192159 ET20, KIT 312 NFM PB L BE ENCHANT 20

  • 192160 ET20, KIT 312 NFM PB T R BE ENCHANT 20 192130 ET20, KIT 312 2.4G NFM 75 R BE ENCHANT 20

  • 192162 ET20, KIT 13 2.4G NFM R BE ENCHANT 20

  • 192163 ET20, KIT 13 2.4G NFM L BE ENCHANT 20

  • 192164 ET20, KIT 13 NFM R BE ENCHANT 20

  • 192165ET20, KIT 13 NFM L BE ENCHANT 20

  • ET 100 CIC (Enchant 100) –186151 ET100, KIT 10 NFM 75 BE ENCHANT 100

  • ET 100 ITE FS (ENCHANT 100) - 186199 ET100, KIT 13 2.4G NFM R BE, 186200 ET100, KIT 13 2.4G NFM L BE, 186201 ET100, KIT 13 NFM R BE, 186202 ET100, KIT 13 NFM L BE

  • ET 100 ITE HS (Enchant 100) - 186166 ET100, KIT 312 2.4G NFM 85 L BE ENCHANT 100

  • ET 20 ITE FS (ENCHANT 20) - 192163 ET20, KIT 13 2.4G NFM L BE , 192162 ET20, KIT 13 2.4G NFM R BE , 192164 ET20, KIT 13 NFM R BE, 192165 ET20, KIT 13 NFM L BE

  • ET 20 ITE HS (Enchant 20) - 192132 ET20, KIT 312 2.4G NFM 85 R BE ENCHANT 20

  • ET 40 ITE FS (ENCHANT 80) - 192116 ET40, KIT 13 2.4G NFM R BE , 192118 ET40, KIT 13 NFM R BE , 192117 ET40, KIT 13 2.4G NFM L BE, 192119 ET40, KIT 13 NFM L BE

  • ET 40 ITE HS (Enchant 40) – 192086 ET40, KIT 312 2.4G NFM 85 R BE ENCHANT 40

  • ET 60 ITE FS (ENCHANT 80) - 186316 ET60, KIT 13 2.4G NFM R BE , 186317 ET60, KIT 13 2.4G NFM L BE , 186318 ET60, KIT 13 NFM R BE, 186319 ET60, KIT 13 NFM L BE

  • ET 60 ITE HS (Enchant 60) – 186282 ET60, KIT 312 2.4G NFM 85 R BE ENCHANT 60

  • ET 80 ITE FS (ENCHANT 80) - 186267 ET80, KIT 13 NFM L BE, 186264 ET80, KIT 13 2.4G NFM R BE, 186265 ET80, KIT 13 2.4G NFM L BE , 186266 ET80, KIT 13 NFM R BE

  • ET 80 ITE HS (Enchant 80) – 186230 ET80, KIT 312 2.4G NFM 85 R BE ENCHANT 80

  • ET80, KIT 10 75 PB BE ENCHANT 80

Instruções de Uso e Arquivos(1)

195150_ET_ITE_FW3_UG_BR_IPR6.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T1732323316/08/2022, 17:10Exp. 4560176221

A atualização destes documentos é executada pela empresa responsável pela regularização do produto.

Documentos Técnicos(6)

439596322628/07/2022

EQUIPAMENTO – Alteração de notificação classe II – Implementação imediata

Publicado deferimento

263874122706/06/2022

EQUIPAMENTO – Retificação – Correção pela ANVISA

Publicado deferimento

250051622228/04/2022

EQUIPAMENTO – Alteração de notificação classe II – Implementação imediata

Publicado deferimento

138375222401/04/2022

EQUIPAMENTO – Alteração de notificação classe II – Implementação imediata

Não anuído

054380222117/02/2022

EQUIPAMENTO – Alteração de notificação classe II – Implementação imediata

Não anuído

042399922710/02/2022

EQUIPAMENTO – Notificação de Dispositivo Médico Classe II

Publicado deferimento

Petição primária

Produtos relacionados

Fonte: Dados Abertos ANVISA + API Oficial ANVISA
Última atualização: 12 de Outubro de 2026
Ver na fonte oficial da ANVISA

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