elıxdata
Dispositivos MédicosAtivo

Sizer Estéril de Implante Mamamário preenchido de Gel de Silicone

80526060011
Informações Gerais

Nome do produto

Sizer Estéril de Implante Mamamário preenchido de Gel de Silicone

Número de registro

80526060011

Nome técnico

Medidor para Implante

Classe de risco

II

Processo

25351731713201988

Empresa Detentora

Razão social

POL-LUX COMÉRCIO, IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS MÉDICO-CIRÚRGICO E HOSPITALAR S/A

CNPJ

10.347.925/0001-67

Fabricante

POLYTECH HEALTH & AESTHETICS GMBH

País de fabricação

ALEMANHA

Registro

Situação

Ativo

Vencimento

Registro vigente

Registro de prazo indeterminado

Histórico de Situação
VálidoATIVO07/05/2026

Detectado a cada sincronização diária com a ANVISA.

Apresentações / Modelos(596)

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  • 20624 –440 H. Meme ® TLS Low Profile – Sublime Line 20724-055 H

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  • 20625 – 600 H Meme ® THS Moderate Profile Sublime Line 20725–070 H

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  • 20626 – 760 H Meme ® THS High Profile Sublime Line 20726-090 H

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  • 20627 – 920 H. Meme ® TXS Extra High Profile Sublime Line 20727–105 H

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  • 20634 – 385 H.Replicon® TLS Low Profile Sublime Line20734–050 H

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  • 20635 - 525 H.Replicon® SL THS Moderate Profile20735 – 065 H

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  • 20636 – 670 H.Replicon® THS High Profile – Sublime Line20736–075H

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  • 20637 – 545 H

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  • 20637 – 810 H.Replicon® TXS Extra High Profile – Sublime Line20737– 095H

  • 20644 – 045 H

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  • 20644 – 245 H

  • 20644 – 270 H

  • 20644 – 295 H

  • 20644 – 325 H. Opticon® TLS Low Profile – Sublime Line 20744 – 045 H

  • 20645 - 070 H

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  • 20645 – 365 H

  • 20645 – 405 H

  • 20645 – 445 H. Opticon® THS Moderate Profile Sublime Line 20745-055 H

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  • 20646 – 560 H. Opticon®THS High Profile Sublime Line 20746–065 H

  • 20676 – 470 H

  • 20676 – 520 H

  • 20676 – 580 H

  • 20676 – 640 H

  • 20676 – 705 H

  • 20676 – 775 H.Optimam® THS High Profile Sublime Line20776–095H

  • 20677 - 450 H

  • 20677 - 940 H.Optimam® TXS Extra High Profile Sublime Line20777-110H

  • 20677 – 120 H

  • 20677 – 145 H

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  • 20724-400 H

  • 20724-440 H

  • 20724-485 H. Meme ® THP Moderate Profile 20625 – 065 H

  • 20725-090 H

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  • 20725-120 H

  • 20725-145 H

  • 20725-165 H

  • 20725-195 H

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  • 20725-400 H

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  • 20725-495 H

  • 20725-545 H

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  • 20725-660 H. Meme ® THP High Profile 20626 – 080 H

  • 20725360 H

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  • 20726-690 H Meme ® TXP Extra High Profile 20627 – 095 H

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  • 20727-485 H

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  • 20727-675 H Opticon® TLP Low Profile 20644 – 040 H

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  • 20734–425H.Replicon® THP Moderate Profile20635 – 060 H

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  • 20735 – 530H

  • 20735-265H

  • 20735-300H

  • 20735– 170H

  • 20735– 580H.Replicon® THP High Profile20636 – 070 H

  • 20736-095H

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  • 20736-130H

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  • 20736-445H

  • 20736-495H

  • 20736-550H

  • 20736-605H

  • 20736-670H

  • 20736-735H.Replicon® TXP Extra High Profile20637 – 085 H

  • 20737-110H

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  • 20737-160H

  • 20737-185H

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  • 20737-255H

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  • 20737-480H

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  • 20737-665H

  • 20737-730H.Diagon/Gel® 4Two RR Regular Round HP HediuH Profile POLYtxt (textured)21621-190H

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  • 20744 – 295 H

  • 20744 – 325 H

  • 20744 – 360 H. Opticon® THP Moderate Profile 20645 – 050 H

  • 20745-065H

  • 20745-075H

  • 20745-095H

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  • 20745-295H

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  • 20745-365H

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  • 20745-445H

  • 20745-490H. Opticon®THP HighProfile 20646 – 060 H

  • 20746-075H

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  • 20746-130H

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  • 20776-415H

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  • 20776-515H

  • 20776-570H

  • 20776-640H

  • 20776-705H.Optimam® TXP Extra High Profile20677 – 100 H

  • 20776–250H

  • 20777-130H

  • 20777-160H

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  • 20777-220H

  • 20777-255H

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  • 20777-335H

  • 20777-385H

  • 20777-440H

  • 20777-495H

  • 20777-555H

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  • 20777-695H.Replicon® TLP Low Profile20634 – 045 H

  • 21621-230H

  • 21621-260H

  • 21621-290H

  • 21621-330H

  • 21621-355H.Diagon/Gel ® 4Two RR Regular Round HP High Profile Diagon POLYtxt (textured)21622-225H

  • 21622-255H

  • 21622-285H

  • 21622-325H

  • 21622-360H

  • 21622-410H.Diagon/Gel® 4Two AR AnatoHical Round HP High Profile POLYtxt (textured)21631-195H

  • 21631-225H

  • 21631-255H

  • 21631-285H

  • 21631-315H

  • 21631-345H

  • 21631-400H

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  • 21632-305H

  • 21632-335H

  • 21632-365H

  • 21632-390H

  • 21632-465H

  • 21632-500H.Diagon/Gel® 4Two AO AnatoHical Oval HP High ProfilePOLYtxt (textured)21641-180H

  • 21634-055H

  • 21634-065H

  • 21634-075H

  • 21634-090H

  • 21634-100H

  • 21634-115H

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  • 21634-215H

  • 21634-240H

  • 21634-265H

  • 21634-290H

  • 21634-320H

  • 21634-355H

  • 21634-385H.Diagon/Gel Replicon® THP Moderate Profile Diagon POLYtxt (textured)21635-060H

  • 21635-070H

  • 21635-085H

  • 21635-100H

  • 21635-115H

  • 21635-135H

  • 21635-155H

  • 21635-175H

  • 21635-200H

  • 21635-230H

  • 21635-255H

  • 21635-290H

  • 21635-320H

  • 21635-355H

  • 21635-395H

  • 21635-435H

  • 21635-480H

  • 21635-525H.Diagon/Gel Replicon® THP High Profile POLYtxt (textured)21636-070H

  • 21636-085H

  • 21636-105H

  • 21636-120H

  • 21636-145H

  • 21636-165H

  • 21636-190H

  • 21636-220H

  • 21636-250H

  • 21636-285H

  • 21636-320H

  • 21636-360H

  • 21636-405H

  • 21636-450H

  • 21636-500H

  • 21636-550H

  • 21636-610H

  • 21636-670H.Diagon/Gel Replicon® TXP Extra High Profile POLYtxt (textured)21637-085H

  • 21637-100H

  • 21637-120H

  • 21637-145H

  • 21637-170H

  • 21637-200H

  • 21637-230H

  • 21637-265H

  • 21637-300H

  • 21637-345H

  • 21637-385H

  • 21637-435H

  • 21637-485H

  • 21637-545H

  • 21637-605H

  • 21637-665H

  • 21637-735H.Opticon® HS LP Low Profile Diagon Texturizada21644-040H

  • 21641-205H

  • 21641-235H

  • 21641-260H

  • 21641-290H

  • 21641-320H

  • 21641-360H.Diagon/Gel® 4Two AO AnatoHical Oval XP Extra High Profile POLYtxt (textured)21642-215H

  • 21642-245H

  • 21642-285H

  • 21642-305H

  • 21642-335H

  • 21642-380H

  • 21642-415H.Diagon/Gel Replicon® TLP Low Profile POLYtxt (textured)21634-045H

  • 21644-045H

  • 21644-055H

  • 21644-065H

  • 21644-075H

  • 21644-085H

  • 21644-100H

  • 21644-110H

  • 21644-125H

  • 21644-145H

  • 21644-160H

  • 21644-180H

  • 21644-200H

  • 21644-220H

  • 21644-245H

  • 21644-270H

  • 21644-295H

  • 21644-325H.Diagon/Gel Opticon® THP Moderate Profile POLYtxt (textured)21645-050H

  • 21645-060H

  • 21645-070H

  • 21645-085H

  • 21645-095H

  • 21645-115H

  • 21645-130H

  • 21645-150H

  • 21645-170H

  • 21645-190H

  • 21645-215H

  • 21645-240H

  • 21645-270H

  • 21645-300H

  • 21645-330H

  • 21645-365H

  • 21645-405H

  • 21645-445H.Diagon/Gel Opticon® THP High Profile POLYtxt (textured)21646-060H

  • 21646-070H

  • 21646-085H

  • 21646-105H

  • 21646-120H

  • 21646-140H

  • 21646-160H

  • 21646-185H

  • 21646-210H

  • 21646-240H

  • 21646-270H

  • 21646-305H

  • 21646-340H

  • 21646-380H

  • 21646-420H

  • 21646-465H

  • 21646-510H

  • 21646-560H.Diagon/Gel Opticon® TXP Extra High Profile POLYtxt (textured)21647-070H

  • 21647-085H

  • 21647-105H

  • 21647-120H

  • 21647-145H

  • 21647-170H

  • 21647-195H

  • 21647-220H

  • 21647-255H

  • 21647-290H

  • 21647-325H

  • 21647-365H

  • 21647-410H

  • 21647-455H

  • 21647-510H

  • 21647-560H

  • 21647-620H

  • 21647-680H

  • 30634 – 215 H

  • Diagon/Gel® 4Two AR AnatoHical Round XP Extra High ProfilePOLYtxt (textured)21632-240H

  • Meme® TLP Low Profile 20624 – 050 H

Instruções de Uso e Arquivos(1)

IFU - Sizer Estéril.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T1533918925/10/2021, 21:48Exp. 4218614211

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

Documentos Técnicos(2)

084653320911/05/2020

MATERIAL - Retificação – Correção pela ANVISA

Publicado deferimento

350878319809/03/2020

MATERIAL - Cadastro de Famílias de Material de Uso Médico

Publicado deferimento

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