elıxdata
Dispositivos MédicosAtivo

Familia de aparelho auditivo intraauricular Bernafon

10356029039
Informações Gerais

Nome do produto

Familia de aparelho auditivo intraauricular Bernafon

Número de registro

10356029039

Nome técnico

Aparelho Auditivo

Classe de risco

II

Processo

25351233031202471

Empresa Detentora

Razão social

CENTRO AUDITIVO TELEX LTDA

CNPJ

33.060.302/0001-04

Fabricante

SBO HEARING A/S

País de fabricação

DINAMARCA

Registro

Situação

Ativo

Vencimento

Registro vigente

Validade prevista: 17/06/2029

Histórico de Situação
VálidoATIVO07/05/2026

Detectado a cada sincronização diária com a ANVISA.

Apresentações / Modelos(275)

  • 242446        ALPHA 9, KIT 312 NFM L

  • 242446        ALPHA 9, KIT 312 NFM L BE

  • 242447        ALPHA 9, KIT 312 NFM PB

  • 242447        ALPHA 9, KIT 312 NFM PB L BE

  • 242448        ALPHA 9, KIT 312 NFM R

  • 242448        ALPHA 9, KIT 312 NFM R BE

  • 242449        ALPHA 9, KIT 312 NFM PB

  • 242449        ALPHA 9, KIT 312 NFM PB R BE

  • 242450        ALPHA 9, KIT 312 NFM 90

  • 242450        ALPHA 9, KIT 312 NFM 90 R BE

  • 242451        ALPHA 9, KIT 312 NFM 90

  • 242451        ALPHA 9, KIT 312 NFM 90 PB R BE

  • 242452        ALPHA 9, KIT 312 NFM 90

  • 242452        ALPHA 9, KIT 312 NFM 90 L BE

  • 242453        ALPHA 9, KIT 312 NFM 90

  • 242453        ALPHA 9, KIT 312 NFM 90 PB L BE

  • 242454        ALPHA 9, KIT 312 2.4G

  • 242454        ALPHA 9, KIT 312 2.4G NFM L BE

  • 242455        ALPHA 9, KIT 312 2.4G

  • 242455        ALPHA 9, KIT 312 2.4G NFM PB L BE

  • 242457        ALPHA 9, KIT 312 2.4G

  • 242457        ALPHA 9, KIT 312 2.4G NFM R BE

  • 242458        ALPHA 9, KIT 312 2.4G

  • 242458        ALPHA 9, KIT 312 2.4G NFM PB R BE

  • 242460        ALPHA 9, KIT 312 2.4G

  • 242460        ALPHA 9, KIT 312 2.4G NFM 90 R BE

  • 242461        ALPHA 9, KIT 312 2.4G

  • 242461        ALPHA 9, KIT 312 2.4G NFM 90 PB R BE

  • 242462        ALPHA 9, KIT 312 2.4G

  • 242462        ALPHA 9, KIT 312 2.4G NFM 90 L BE

  • 242463        ALPHA 9, KIT 312 2.4G

  • 242463        ALPHA 9, KIT 312 2.4G NFM 90 PB L BE

  • 242464        ALPHA 9, KIT 312 2.4G

  • 242464        ALPHA 9, KIT 312 2.4G NFM L BL

  • 242465        ALPHA 9, KIT 312 2.4G

  • 242465        ALPHA 9, KIT 312 2.4G NFM R BL

  • 242466        ALPHA 9, KIT 312 NFM L

  • 242466        ALPHA 9, KIT 312 NFM L BL

  • 242467        ALPHA 9, KIT 312 NFM R

  • 242467        ALPHA 9, KIT 312 NFM R BL

  • 242493        ALPHA 9, KIT 312 NFM L

  • 242494        ALPHA 9, KIT 312 NFM PB

  • 242495        ALPHA 9, KIT 312 NFM R

  • 242496        ALPHA 9, KIT 312 NFM PB

  • 242497        ALPHA 9, KIT 312 NFM 90

  • 242498        ALPHA 9, KIT 312 NFM 90

  • 242499        ALPHA 9, KIT 312 NFM 90

  • 242500        ALPHA 9, KIT 312 NFM 90

  • 242501        ALPHA 9, KIT 312 2.4G

  • 242502        ALPHA 9, KIT 312 2.4G

  • 242503        ALPHA 9, KIT 312 2.4G

  • 242504        ALPHA 9, KIT 312 2.4G

  • 242505        ALPHA 9, KIT 312 2.4G

  • 242506        ALPHA 9, KIT 312 2.4G

  • 242507        ALPHA 9, KIT 312 2.4G

  • 242508        ALPHA 9, KIT 312 2.4G

  • 242509        ALPHA 9, KIT 312 2.4G

  • 242510        ALPHA 9, KIT 312 2.4G

  • 242511        ALPHA 9, KIT 312 NFM L

  • 242512        ALPHA 9, KIT 312 NFM R

  • 243401        ALPHA 9, KIT 10 75 BE

  • 243403        ALPHA 9, KIT 10 90 BE

  • 243404        ALPHA 9 KIT IIC 10 90 BL

  • 243405        ALPHA 9, KIT 10 75 PB

  • 243405        ALPHA 9, KIT 10 75 PB BE

  • 243406        ALPHA 9, KIT 10 90 PB

  • 243406        ALPHA 9, KIT 10 90 PB BE

  • 243407        ALPHA 9, KIT 10 NFM 75

  • 243407        ALPHA 9, KIT 10 NFM 75 BE

  • 243408        ALPHA 9, KIT 10 NFM 90

  • 243408        ALPHA 9, KIT 10 NFM 90 BE

  • 243409        ALPHA 9, KIT 10 NFM 75

  • 243409        ALPHA 9, KIT 10 NFM 75 PB BE

  • 243410        ALPHA 9, KIT 10 NFM 90

  • 243410        ALPHA 9, KIT 10 NFM 90 PB BE

  • 243418        ALPHA 9, KIT 10 75 BE

  • 243420        ALPHA 9, KIT 10 90 BE

  • 243422        ALPHA 9, KIT 10 75 PB

  • 243423        ALPHA 9, KIT 10 90 PB

  • 243424        ALPHA 9, KIT 10 NFM 75

  • 243425        ALPHA 9, KIT 10 NFM 90

  • 243426        ALPHA 9, KIT 10 NFM 75

  • 243427        ALPHA 9, KIT 10 NFM 90

  • 245372        BERNAFON ALPHA 9 CIC

  • 245373        BERNAFON ALPHA 9 ITC

  • 245374        BERNAFON ALPHA 9 ITE HS

  • 245375        BERNAFON ALPHA 9 ITE FS

  • 245382        BERNAFON ALPHA 5 CIC

  • 245383        BERNAFON ALPHA 5 ITC

  • 245384        BERNAFON ALPHA 5 ITE HS

  • 245385        BERNAFON ALPHA 5 ITE FS

  • 245392        BERNAFON ALPHA 1 CIC

  • 245393        BERNAFON ALPHA 1 ITC

  • 245394        BERNAFON ALPHA 1 ITE HS

  • 245395        BERNAFON ALPHA 1 ITE FS

  • 246385        ALPHA 5, KIT 312 NFM L BE

  • 246386        ALPHA 5, KIT 312 NFM PB

  • 246386        ALPHA 5, KIT 312 NFM PB L BE

  • 246387        ALPHA 5, KIT 312 NFM R BE

  • 246388        ALPHA 5, KIT 312 NFM PB

  • 246388        ALPHA 5, KIT 312 NFM PB R BE

  • 246389        ALPHA 5, KIT 312 NFM 90

  • 246389        ALPHA 5, KIT 312 NFM 90 R BE

  • 246390        ALPHA 5, KIT 312 NFM 90

  • 246390        ALPHA 5, KIT 312 NFM 90 PB R BE

  • 246391        ALPHA 5, KIT 312 NFM 90

  • 246391        ALPHA 5, KIT 312 NFM 90 L BE

  • 246392        ALPHA 5, KIT 312 NFM 90

  • 246392        ALPHA 5, KIT 312 NFM 90 PB L BE

  • 246393        ALPHA 5, KIT 312 2.4G

  • 246393        ALPHA 5, KIT 312 2.4G NFM L BE

  • 246394        ALPHA 5, KIT 312 2.4G

  • 246394        ALPHA 5, KIT 312 2.4G NFM PB L BE

  • 246395        ALPHA 5, KIT 312 2.4G

  • 246395        ALPHA 5, KIT 312 2.4G NFM R BE

  • 246396        ALPHA 5, KIT 312 2.4G

  • 246396        ALPHA 5, KIT 312 2.4G NFM PB R BE

  • 246397        ALPHA 5, KIT 312 2.4G

  • 246397        ALPHA 5, KIT 312 2.4G NFM 90 R BE

  • 246398        ALPHA 5, KIT 312 2.4G

  • 246398        ALPHA 5, KIT 312 2.4G NFM 90 PB R BE

  • 246399        ALPHA 5, KIT 312 2.4G

  • 246399        ALPHA 5, KIT 312 2.4G NFM 90 L BE

  • 246400        ALPHA 5, KIT 312 2.4G

  • 246400        ALPHA 5, KIT 312 2.4G NFM 90 PB L BE

  • 246401        ALPHA 5, KIT 312 2.4G

  • 246401        ALPHA 5, KIT 312 2.4G NFM L BL

  • 246402        ALPHA 5, KIT 312 2.4G

  • 246402        ALPHA 5, KIT 312 2.4G NFM R BL

  • 246403        ALPHA 5, KIT 312 NFM L

  • 246403        ALPHA 5, KIT 312 NFM L BL

  • 246404        ALPHA 5, KIT 312 NFM R

  • 246404        ALPHA 5, KIT 312 NFM R BL

  • 246454        ALPHA 1, KIT 312 NFM L

  • 246454        ALPHA 1, KIT 312 NFM L BE

  • 246455        ALPHA 1, KIT 312 NFM PB

  • 246455        ALPHA 1, KIT 312 NFM PB L BE

  • 246456        ALPHA 1, KIT 312 NFM R

  • 246456        ALPHA 1, KIT 312 NFM R BE

  • 246457        ALPHA 1, KIT 312 NFM PB

  • 246457        ALPHA 1, KIT 312 NFM PB R BE

  • 246458        ALPHA 1, KIT 312 NFM 90

  • 246458        ALPHA 1, KIT 312 NFM 90 R BE

  • 246459        ALPHA 1, KIT 312 NFM 90

  • 246459        ALPHA 1, KIT 312 NFM 90 PB R BE

  • 246460        ALPHA 1, KIT 312 NFM 90

  • 246460        ALPHA 1, KIT 312 NFM 90 L BE

  • 246461        ALPHA 1, KIT 312 NFM 90

  • 246461        ALPHA 1, KIT 312 NFM 90 PB L BE

  • 246462        ALPHA 1, KIT 312 2.4G

  • 246462        ALPHA 1, KIT 312 2.4G NFM L BE

  • 246463        ALPHA 1, KIT 312 2.4G

  • 246463        ALPHA 1, KIT 312 2.4G NFM PB L BE

  • 246464        ALPHA 1, KIT 312 2.4G

  • 246464        ALPHA 1, KIT 312 2.4G NFM R BE

  • 246465        ALPHA 1, KIT 312 2.4G

  • 246465        ALPHA 1, KIT 312 2.4G NFM PB R BE

  • 246466        ALPHA 1, KIT 312 2.4G

  • 246466        ALPHA 1, KIT 312 2.4G NFM 90 R BE

  • 246467        ALPHA 1, KIT 312 2.4G

  • 246467        ALPHA 1, KIT 312 2.4G NFM 90 PB R BE

  • 246468        ALPHA 1, KIT 312 2.4G

  • 246468        ALPHA 1, KIT 312 2.4G NFM 90 L BE

  • 246469        ALPHA 1, KIT 312 2.4G

  • 246469        ALPHA 1, KIT 312 2.4G NFM 90 PB L BE

  • 246470        ALPHA 1, KIT 312 2.4G

  • 246470        ALPHA 1, KIT 312 2.4G NFM L BL

  • 246471        ALPHA 1, KIT 312 2.4G

  • 246471        ALPHA 1, KIT 312 2.4G NFM R BL

  • 246472        ALPHA 1, KIT 312 NFM L

  • 246472        ALPHA 1, KIT 312 NFM L BL

  • 246473        ALPHA 1, KIT 312 NFM R

  • 246473        ALPHA 1, KIT 312 NFM R BL

  • 248244        ALPHA 5, KIT 10 75 BE

  • 248246        ALPHA 5, KIT 10 90 BE

  • 248247        ALPHA 5 KIT IIC 10 90 BL

  • 248248        ALPHA 5, KIT 10 75 PB

  • 248248        ALPHA 5, KIT 10 75 PB BE

  • 248249        ALPHA 5, KIT 10 90 PB

  • 248249        ALPHA 5, KIT 10 90 PB BE

  • 248250        ALPHA 5, KIT 10 NFM 75 BE

  • 248251        ALPHA 5, KIT 10 NFM 90 BE

  • 248252        ALPHA 5, KIT 10 NFM 75

  • 248252        ALPHA 5, KIT 10 NFM 75 PB BE

  • 248253        ALPHA 5, KIT 10 NFM 90

  • 248253        ALPHA 5, KIT 10 NFM 90 PB BE

  • 248264        ALPHA 1, KIT 10 75 BE

  • 248266        ALPHA 1, KIT 10 90 BE

  • 248267        ALPHA 1 KIT IIC 10 90 BL

  • 248268        ALPHA 1, KIT 10 75 PB

  • 248268        ALPHA 1, KIT 10 75 PB BE

  • 248269        ALPHA 1, KIT 10 90 PB

  • 248269        ALPHA 1, KIT 10 90 PB BE

  • 248270        ALPHA 1, KIT 10 NFM 75

  • 248270        ALPHA 1, KIT 10 NFM 75 BE

  • 248271        ALPHA 1, KIT 10 NFM 90

  • 248271        ALPHA 1, KIT 10 NFM 90 BE

  • 248272        ALPHA 1, KIT 10 NFM 75

  • 248272        ALPHA 1, KIT 10 NFM 75 PB BE

  • 248273        ALPHA 1, KIT 10 NFM 90

  • 248273        ALPHA 1, KIT 10 NFM 90 PB BE

  • 271102 ENCANTA 400 KIT 10 75 BE

  • 271103 ENCANTA 400 KIT IIC 10 75 BL

  • 271104 ENCANTA 400 KIT 10 90 BE

  • 271105 ENCANTA 400 KIT IIC 10 90 BL

  • 271106 ENCANTA 400 KIT 10 NFM 75 BE

  • 271107 ENCANTA 400 KIT 10 NFM 90 BE

  • 271108 ENCANTA 300 KIT 10 75 BE

  • 271109 ENCANTA 300 KIT IIC 10 75 BL

  • 271110 ENCANTA 300 KIT 10 90 BE

  • 271111 ENCANTA 300 KIT IIC 10 90 BL

  • 271112 ENCANTA 300 KIT 10 NFM 75 BE

  • 271113 ENCANTA 300 KIT 10 NFM 90 BE

  • 271114 ENCANTA 200 KIT 10 75 BE

  • 271115 ENCANTA 200 KIT IIC 10 75 BL

  • 271116 ENCANTA 200 KIT 10 90 BE

  • 271117 ENCANTA 200 KIT IIC 10 90 BL

  • 271118 ENCANTA 200 KIT 10 NFM 75 BE, 271119 ENCANTA 200 KIT 10 NFM 90 BE

  • 271120 ENCANTA 100 KIT 10 75 BE

  • 271121 ENCANTA 100 KIT IIC 10 75 BL

  • 271122 ENCANTA 100 KIT 10 90 BE

  • 271123 ENCANTA 100 KIT IIC 10 90 BL

  • 271124 ENCANTA 100 KIT 10 NFM 75 BE

  • 271125 ENCANTA 100 KIT 10 NFM 90 BE

  • 271199 BERNAFON ENCANTA 400 IIC

  • 271200 BERNAFON ENCANTA 400 CIC

  • 271201 BERNAFON ENCANTA 300 IIC

  • 271202 BERNAFON ENCANTA 300 CIC

  • 271203 BERNAFON ENCANTA 200 IIC

  • 271204 BERNAFON ENCANTA 200 CIC

  • 271205 BERNAFON ENCANTA 100 IIC

  • 271206 BERNAFON ENCANTA 100 CIC

  • 273674 ENCANTA 400 KIT 10 75 BE RND

  • 273675 ENCANTA 400 KIT IIC 10 75 BL RND

  • 273676 ENCANTA 400 KIT 10 90 BE RND

  • 273677 ENCANTA 400 KIT IIC 10 90 BL RND

  • 273678 ENCANTA 400 KIT 10 NFM 75 BE RND

  • 273679 ENCANTA 400 KIT 10 NFM 90 BE RND

  • 276802 ENTRA B 20 KIT 312 NFM L BE

  • 276804 ENTRA B 20 KIT 312 NFM R BE

  • 276810 ENTRA B 20 KIT 312 2.4G NFM L BE

  • 276812 ENTRA B 20 KIT 312 2.4G NFM R BE

  • 276822 ENTRA B 10 KIT 312 NFM L BE

  • 276824 ENTRA B 10 KIT 312 NFM R BE

  • 276830 ENTRA B 10 KIT 312 2.4G NFM L BE

  • 276832 ENTRA B 10 KIT 312 2.4G NFM R BE

  • 276892 BERNAFON ENTRA B 20 IIC

  • 276893 BERNAFON ENTRA B 20 CIC

  • 276894 BERNAFON ENTRA B 20 ITC

  • 276895 BERNAFON ENTRA B 20 ITE HS

  • 276896 BERNAFON ENTRA B 20 ITE FS

  • 276897 BERNAFON ENTRA B 10 IIC

  • 276898 BERNAFON ENTRA B 10 CIC

  • 276899 BERNAFON ENTRA B 10 ITC

  • 276900 BERNAFON ENTRA B 10 ITE HS

  • 276901 BERNAFON ENTRA B 10 ITE FS

  • 280332 ENTRA B 20 KIT 10 75 BE

  • 280333 ENTRA B 20 KIT IIC 10 75 BL

  • 280334 ENTRA B 20 KIT 10 90 BE

  • 280335 ENTRA B 20 KIT IIC 10 90 BL

  • 280336 ENTRA B 20 KIT 10 NFM 75 BE

  • 280337 ENTRA B 20 KIT 10 NFM 90 BE

  • 280338 ENTRA B 10 KIT 10 75 BE

  • 280339 ENTRA B 10 KIT IIC 10 75 BL

  • 280340 ENTRA B 10 KIT 10 90 BE

  • 280341 ENTRA B 10 KIT IIC 10 90 BL

  • 280342 ENTRA B 10 KIT 10 NFM 75 BE

  • 280343 ENTRA B 10 KIT 10 NFM 90 BE

  • ALPHA 1 KIT IIC 10 75 BL ou ALPHA 1 KIT IIC 10 75 BL INSTANTFIT

  • ALPHA 5 KIT IIC 10 75 BL ou ALPHA 5 KIT IIC 10 75 BL INSTANT FIT

  • ALPHA 9 KIT IIC 10 75 BL ou ALPHA 9 KIT IIC 10 75 BL INSTANTFIT

  • ALPHA 9 KIT IIC 10 75 BL ou ALPHA 9 KIT IIC 10 75 BL INSTANTFIT

  • BERNAFON ALPHA 1 IIC ou BERNAFON ALPHA 1 IIC INSTANTFIT

  • BERNAFON ALPHA 5 IIC ou BERNAFON ALPHA 5 IIC INSTANTFIT

  • BERNAFON ALPHA 9 IIC ou BERNAFON ALPHA 9 IIC INSTANTFIT

Instruções de Uso e Arquivos(4)

213703_BF_TV-A_IFU_2020_BR.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

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249837BR_IFU_BF_AH_CUSTOM_H2-22.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3549575102/02/2026, 13:31Exp. 0105150266
280574BR_IFU_BE_Encanta_IIC_CIC_25.1.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3549575202/02/2026, 13:31Exp. 0105150266
280628BR_IFU_BE_Entra_B_Custom_25.1.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3549575302/02/2026, 13:31Exp. 0105150266

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

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Fonte: Dados Abertos ANVISA + API Oficial ANVISA
Última atualização: 12 de Outubro de 2026
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