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Dispositivos MédicosAtivo

Familia de Aparelhos auditivos intraauriculares Oticon

10356029029
Informações Gerais

Nome do produto

Familia de Aparelhos auditivos intraauriculares Oticon

Número de registro

10356029029

Nome técnico

Aparelho Auditivo

Classe de risco

II

Processo

25351638373202301

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: 30/10/2028

Histórico de Situação
VálidoATIVO07/05/2026

Detectado a cada sincronização diária com a ANVISA.

Apresentações / Modelos(228)

  • 246475 OWN 1, KIT 312 NFM L C001

  • 246476 OWN 1, KIT 312 NFM PB L C001

  • 246477 OWN 1, KIT 312 NFM R C001

  • 246478 OWN 1, KIT 312 NFM PB R C001

  • 246479 OWN 1, KIT 312 NFM 90 R C001

  • 246480 OWN 1, KIT 312 NFM 90 PB R C001

  • 246481 OWN 1, KIT 312 NFM 90 L C001

  • 246482 OWN 1, KIT 312 NFM 90 PB L C001

  • 246483 OWN 1, KIT 312 2.4G NFM L C001

  • 246484 OWN 1, KIT 312 2.4G NFM PB L C001

  • 246485 OWN 1, KIT 312 2.4G NFM R C001

  • 246486 OWN 1, KIT 312 2.4G NFM PB R C001

  • 246487 OWN 1, KIT 312 2.4G NFM 90 R C001

  • 246488 OWN 1, KIT 312 2.4G NFM 90 PB R C001

  • 246489 OWN 1, KIT 312 2.4G NFM 90 L C001

  • 246490 OWN 1, KIT 312 2.4G NFM 90 PB L C001

  • 246491 OWN 1, KIT 312 2.4G NFM L C005

  • 246492 OWN 1, KIT 312 2.4G NFM R C005

  • 246493 OWN 1, KIT 312 NFM L C005

  • 246494 OWN 1, KIT 312 NFM R C005

  • 246495 OWN 2, KIT 312 NFM L C001

  • 246496 OWN 2, KIT 312 NFM PB L C001

  • 246497 OWN 2, KIT 312 NFM R C001

  • 246498 OWN 2, KIT 312 NFM PB R C001

  • 246499 OWN 2, KIT 312 NFM 90 R C001

  • 246500 OWN 2, KIT 312 NFM 90 PB R C001

  • 246501 OWN 2, KIT 312 NFM 90 L C001

  • 246502 OWN 2, KIT 312 NFM 90 PB L C001

  • 246503 OWN 2, KIT 312 2.4G NFM L C001

  • 246504 OWN 2, KIT 312 2.4G NFM PB L C001

  • 246505 OWN 2, KIT 312 2.4G NFM R C001

  • 246506 OWN 2, KIT 312 2.4G NFM PB R C001

  • 246507 OWN 2, KIT 312 2.4G NFM 90 R C001

  • 246508 OWN 2, KIT 312 2.4G NFM 90 PB R C001

  • 246509 OWN 2, KIT 312 2.4G NFM 90 L C001

  • 246510 OWN 2, KIT 312 2.4G NFM 90 PB L C001

  • 246511 OWN 2, KIT 312 2.4G NFM L C005

  • 246512 OWN 2, KIT 312 2.4G NFM R C005

  • 246513 OWN 2, KIT 312 NFM L C005

  • 246514 OWN 2, KIT 312 NFM R C005

  • 246515 OWN 3, KIT 312 NFM L C001

  • 246516 OWN 3, KIT 312 NFM PB L C001

  • 246517 OWN 3, KIT 312 NFM R C001

  • 246518 OWN 3, KIT 312 NFM PB R C001

  • 246519 OWN 3, KIT 312 NFM 90 R C001

  • 246520 OWN 3, KIT 312 NFM 90 PB R C001

  • 246521 OWN 3, KIT 312 NFM 90 L C001

  • 246522 OWN 3, KIT 312 NFM 90 PB L C001

  • 246523 OWN 3, KIT 312 2.4G NFM L C001

  • 246524 OWN 3, KIT 312 2.4G NFM PB L C001

  • 246525 OWN 3, KIT 312 2.4G NFM R C001

  • 246526 OWN 3, KIT 312 2.4G NFM PB R C001

  • 246527 OWN 3, KIT 312 2.4G NFM 90 R C001

  • 246528 OWN 3, KIT 312 2.4G NFM 90 PB R C001

  • 246529 OWN 3, KIT 312 2.4G NFM 90 L C001

  • 246530 OWN 3, KIT 312 2.4G NFM 90 PB L C001

  • 246531 OWN 3, KIT 312 2.4G NFM L C005

  • 246532 OWN 3, KIT 312 2.4G NFM R C005

  • 246533 OWN 3, KIT 312 NFM L C005

  • 246534 OWN 3, KIT 312 NFM R C005

  • 246535 OWN 4, KIT 312 NFM L C001

  • 246536 OWN 4, KIT 312 NFM PB L C001

  • 246537 OWN 4, KIT 312 NFM R C001

  • 246538 OWN 4, KIT 312 NFM PB R C001

  • 246539 OWN 4, KIT 312 NFM 90 R C001

  • 246540 OWN 4, KIT 312 NFM 90 PB R C001

  • 246541 OWN 4, KIT 312 NFM 90 L C001

  • 246542 OWN 4, KIT 312 NFM 90 PB L C001

  • 246543 OWN 4, KIT 312 2.4G NFM L C001

  • 246544 OWN 4, KIT 312 2.4G NFM PB L C001

  • 246545 OWN 4, KIT 312 2.4G NFM R C001

  • 246546 OWN 4, KIT 312 2.4G NFM PB R C001

  • 246547 OWN 4, KIT 312 2.4G NFM 90 R C001

  • 246548 OWN 4, KIT 312 2.4G NFM 90 PB R C001

  • 246549 OWN 4, KIT 312 2.4G NFM 90 L C001

  • 246550 OWN 4, KIT 312 2.4G NFM 90 PB L C001

  • 246551 OWN 4, KIT 312 2.4G NFM L C005

  • 246552 OWN 4, KIT 312 2.4G NFM R C005

  • 246553 OWN 4, KIT 312 NFM L C005

  • 246554 OWN 4, KIT 312 NFM R C005

  • 246555 OWN 5, KIT 312 2.4G NFM 90 L C001

  • 246555 OWN 5, KIT 312 NFM L C001

  • 246556 OWN 5, KIT 312 NFM PB L C001

  • 246557 OWN 5, KIT 312 NFM R C001

  • 246558 OWN 5, KIT 312 NFM PB R C001

  • 246559 OWN 5, KIT 312 NFM 90 R C001

  • 246560 OWN 5, KIT 312 NFM 90 PB R C001

  • 246561 OWN 5, KIT 312 NFM 90 L C001

  • 246562 OWN 5, KIT 312 NFM 90 PB L C001

  • 246563 OWN 5, KIT 312 2.4G NFM L C001

  • 246564 OWN 5, KIT 312 2.4G NFM PB L C001

  • 246565 OWN 5, KIT 312 2.4G NFM R C001

  • 246566 OWN 5, KIT 312 2.4G NFM PB R C001

  • 246567 OWN 5, KIT 312 2.4G NFM 90 R C001

  • 246568 OWN 5, KIT 312 2.4G NFM 90 PB R C001

  • 246569 OWN 5, KIT 312 2.4G NFM 90 L C001

  • 246570 OWN 5, KIT 312 2.4G NFM 90 PB L C001

  • 246571 OWN 5, KIT 312 2.4G NFM L C005

  • 246572 OWN 5, KIT 312 2.4G NFM R C005

  • 246573 OWN 5, KIT 312 NFM L C005

  • 246574 OWN 5, KIT 312 NFM R C005

  • 248822 OWN 1, KIT 10 75 C001

  • 248823 OWN 1 KIT IIC 10 75 C005

  • 248824 OWN 1, KIT 10 90 C001

  • 248825 OWN 1 KIT IIC 10 90 C005

  • 248826 OWN 1, KIT 10 75 PB C001

  • 248827 OWN 1, KIT 10 90 PB C001

  • 248828 OWN 1, KIT 10 NFM 75 C001

  • 248829 OWN 1, KIT 10 NFM 90 C001

  • 248830 OWN 1, KIT 10 NFM 75 PB C001

  • 248831 OWN 1, KIT 10 NFM 90 PB C001

  • 248832 OWN 2, KIT 10 75 C001

  • 248833 OWN 2, KIT IIC 10 75 C005

  • 248834 OWN 2, KIT 10 90 C001

  • 248835 OWN 2, KIT IIC 10 90 C005

  • 248836 OWN 2, KIT 10 75 PB C001

  • 248837 OWN 2, KIT 10 90 PB C001

  • 248838 OWN 2, KIT 10 NFM 75 C001

  • 248839 OWN 2, KIT 10 NFM 90 C001

  • 248840 OWN 2, KIT 10 NFM 75 PB C001

  • 248841 OWN 2, KIT 10 NFM 90 PB C001

  • 248842 OWN 3, KIT 10 75 C001

  • 248843 OWN 3, KIT IIC 10 75 C005

  • 248844 OWN 3, KIT 10 90 C001

  • 248845 OWN 3, KIT IIC 10 90 C005

  • 248846 OWN 3, KIT 10 75 PB C001

  • 248847 OWN 3, KIT 10 90 PB C001

  • 248848 OWN 3, KIT 10 NFM 75 C001

  • 248849 OWN 3, KIT 10 NFM 90 C001

  • 248850 OWN 3, KIT 10 NFM 75 PB C001

  • 248851 OWN 3, KIT 10 NFM 90 PB C001

  • 248852 OWN 4, KIT 10 75 C001

  • 248853 OWN 4, KIT IIC 10 75 C005

  • 248854 OWN 4, KIT 10 90 C001

  • 248855 OWN 4, KIT IIC 10 90 C005

  • 248856 OWN 4, KIT 10 75 PB C001

  • 248857 OWN 4, KIT 10 90 PB C001

  • 248858 OWN 4, KIT 10 NFM 75 C001

  • 248859 OWN 4, KIT 10 NFM 90 C001

  • 248860 OWN 4, KIT 10 NFM 75 PB C001

  • 248861 OWN 4, KIT 10 NFM 90 PB C001

  • 248863 OWN 5, KIT IIC 10 75 C005

  • 248865 OWN 5, KIT IIC 10 90 C005

  • 248866 OWN 5, KIT 10 75 PB C001

  • 248867 OWN 5, KIT 10 90 PB C001

  • 248868 OWN 5, KIT 10 NFM 75 C001

  • 248869 OWN 5, KIT 10 NFM 90 C001

  • 248870 OWN 5, KIT 10 NFM 75 PB C001

  • 248871 OWN 5, KIT 10 NFM 90 PB C001

  • 271126 OWN SI 1 KIT 10 75 C001

  • 271127 OWN SI 1 KIT IIC 10 75 C005

  • 271128 OWN SI 1 KIT 10 90 C001

  • 271129 OWN SI 1 KIT IIC 10 90 C005

  • 271130 OWN SI 1 KIT 10 NFM 75 C001

  • 271131 OWN SI 1 KIT 10 NFM 90 C001

  • 271132 OWN SI 2 KIT 10 75 C001

  • 271133 OWN SI 2 KIT IIC 10 75 C005

  • 271135 OWN SI 2 KIT IIC 10 90 C005

  • 271136 OWN SI 2 KIT 10 NFM 75 C001

  • 271137 OWN SI 2 KIT 10 NFM 90 C001

  • 271138 OWN SI 3 KIT 10 75 C001

  • 271139 OWN SI 3 KIT IIC 10 75 C005

  • 271140 OWN SI 3 KIT 10 90 C001

  • 271141 OWN SI 3 KIT IIC 10 90 C005

  • 271142 OWN SI 3 KIT 10 NFM 75 C001

  • 271143 OWN SI 3 KIT 10 NFM 90 C001

  • 271144 OWN SI 4 KIT 10 75 C001

  • 271145 OWN SI 4 KIT IIC 10 75 C005

  • 271146 OWN SI 4 KIT 10 90 C001

  • 271147 OWN SI 4 KIT IIC 10 90 C005

  • 271148 OWN SI 4 KIT 10 NFM 75 C001

  • 271149 OWN SI 4 KIT 10 NFM 90 C001

  • 271191 OTICON OWN SI 1 IIC

  • 271192 OTICON OWN SI 1 CIC

  • 271193 OTICON OWN SI 2 IIC

  • 271194 OTICON OWN SI 2 CIC

  • 271195 OTICON OWN SI 3 IIC

  • 271196 OTICON OWN SI 3 CIC

  • 271197 OTICON OWN SI 4 IIC

  • 271198 OTICON OWN SI 4 CIC

  • 276762 JET PX 1 KIT 312 NFM L C001

  • 276764 JET PX 1 KIT 312 NFM R C001

  • 276766 JET PX 1 KIT 312 NFM 90 R C001

  • 276768 JET PX 1 KIT 312 NFM 90 L C001

  • 276770 JET PX 1 KIT 312 2.4G NFM L C001

  • 276772 JET PX 1 KIT 312 2.4G NFM R C001

  • 276774 JET PX 1 KIT 312 2.4G NFM 90 R C

  • 276774 JET PX 1 KIT 312 2.4G NFM 90 R C001

  • 276776 JET PX 1 KIT 312 2.4G NFM 90 L C

  • 276776 JET PX 1 KIT 312 2.4G NFM 90 L C001

  • 276778 JET PX 1 KIT 312 2.4G NFM L C005

  • 276779 JET PX 1 KIT 312 2.4G NFM R C005

  • 276780 JET PX 1 KIT 312 NFM L C005

  • 276781 JET PX 1 KIT 312 NFM R C005

  • 276782 JET PX 2 KIT 312 NFM L C001

  • 276784 JET PX 2 KIT 312 NFM R C001

  • 276786 JET PX 2 KIT 312 NFM 90 R C001

  • 276788 JET PX 2 KIT 312 NFM 90 L C001

  • 276790 JET PX 2 KIT 312 2.4G NFM L C001

  • 276792 JET PX 2 KIT 312 2.4G NFM R C001

  • 276794 JET PX 2 KIT 312 2.4G NFM 90 R C001

  • 276796 JET PX 2 KIT 312 2.4G NFM 90 L C001

  • 276798 JET PX 2 KIT 312 2.4G NFM L C005

  • 276799 JET PX 2 KIT 312 2.4G NFM R C005

  • 276800 JET PX 2 KIT 312 NFM L C005

  • 276801 JET PX 2 KIT 312 NFM R C005

  • 276882 OTICON JET PX 1 IIC

  • 276883 OTICON JET PX 1 CIC

  • 276884 OTICON JET PX 1 ITC

  • 276885 OTICON JET PX 1 ITE HS

  • 276886 OTICON JET PX 1 ITE FS

  • 276887 OTICON JET PX 2 IIC

  • 276888 OTICON JET PX 2 CIC

  • 276889 OTICON JET PX 2 ITC

  • 276890 OTICON JET PX 2 ITE HS

  • 276891 OTICON JET PX 2 ITE FS

  • 280344 JET PX 1 KIT 10 75 C001

  • 280345 JET PX 1 KIT IIC 10 75 C005

  • 280346 JET PX 1 KIT 10 90 C001

  • 280347 JET PX 1 KIT IIC 10 90 C005

  • 280348 JET PX 1 KIT 10 NFM 75 C001

  • 280349 JET PX 1 KIT 10 NFM 90 C001

  • 280350 JET PX 2 KIT 10 75 C001

  • 280351 JET PX 2 KIT IIC 10 75 C005

  • 280352 JET PX 2 KIT 10 90 C001

  • 280353 JET PX 2 KIT IIC 10 90 C005

  • 280354 JET PX 2 KIT 10 NFM 75 C001

  • 280355 JET PX 2 KIT 10 NFM 90 C001

Instruções de Uso e Arquivos(8)

220014BR_IFU_EduMic_MDR.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3593623825/02/2026, 18:06Exp. 0186973268
220281BR_IFU_2.4G_Connectclip_1.0_MDR.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3593624025/02/2026, 18:06Exp. 0186973268
236934BR_IFU_Oticon_CROS_MDR.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3593623925/02/2026, 18:06Exp. 0186973268
249739BR_IFU_OT_Own_Custom_H2-22.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3593624125/02/2026, 18:06Exp. 0186973268
280542BR_IFU_OT_Own_SI_IIC_CIC_25.1.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3593624325/02/2026, 18:06Exp. 0186973268
280665BR_IFU_OT_Jet_PX_Custom_25.1.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3593624225/02/2026, 18:06Exp. 0186973268
214157BR_IFU_2.4G_TV_Adapter_3.0_MDR.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3593623625/02/2026, 18:06Exp. 0186973268
220040BR_IFU_2.4G_Remote_Control_3.0_MDR.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3593623725/02/2026, 18:06Exp. 0186973268

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
Ver na fonte oficial da ANVISA

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