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Dispositivos MédicosAtivo

THERMOLYN

10292010094
Informações Gerais

Nome do produto

THERMOLYN

Número de registro

10292010094

Nome técnico

Componentes de Orteses e Proteses Externas

Classe de risco

I

Processo

25351228830202264

Empresa Detentora

Razão social

OTTO BOCK DO BRASIL TECNICA ORTOPEDICA LTDA

CNPJ

42.463.513/0001-89

Fabricante

OTTOBOCK SE & CO KGAA

País de fabricação

ALEMANHA

Registro

Situação

Ativo

Vencimento

Registro vigente

Validade prevista: 31/03/2027

Histórico de Situação
VálidoATIVO07/05/2026

Detectado a cada sincronização diária com a ANVISA.

Apresentações / Modelos(287)

  • 616T111=12 ThermoLyn supra soft plus Silicone

  • 616T111=800X800X12 ThermoLyn supra soft plus Silicone

  • 616T111=9 ThermoLyn supra soft plus Silicone

  • 616T112=1.5-99 ThermoLyn supra flexible, transparent

  • 616T112=2-0 ThermoLyn Supra Flexible Beige

  • 616T112=2-12.1 ThermoLyn supra flexible, neon pink

  • 616T112=2-16 ThermoLyn supra flexible, silver

  • 616T112=2-17 ThermoLyn supra flexible, gold

  • 616T112=2-2 ThermoLyn supra flexible, red

  • 616T112=2-2.4 ThermoLyn supra flexi., light red trans

  • 616T112=2-2.5 ThermoLyn supra flexible, bordeaux

  • 616T112=2-3 ThermoLyn supra flexible, green

  • 616T112=2-3.4 ThermoLyn supra flexible, neon green

  • 616T112=2-4.1 ThermoLyn supra flexible, neon yellow

  • 616T112=2-5 ThermoLyn supra flexible, blue

  • 616T112=2-5.3 ThermoLyn supra flexible, light blue

  • 616T112=2-5.5 ThermoLyn supra flex.,dark blue transl

  • 616T112=2-6 ThermoLyn supra flexible, white

  • 616T112=2-7 ThermoLyn supra flexible, black

  • 616T112=2-99 ThermoLyn supra flexible, transparent

  • 616T112=3-0 ThermoLyn Supra Flexible Beige

  • 616T112=3-99 ThermoLyn supra flexible, transparent

  • 616T112=4-0 ThermoLyn Supra Flexible Beige

  • 616T112=4-12.1 ThermoLyn supra flex., neon pink

  • 616T112=4-16 ThermoLyn supra flexible, silver

  • 616T112=4-17 ThermoLyn supra flexible, gold

  • 616T112=4-2 ThermoLyn supra flexible, red

  • 616T112=4-2.4 ThermoLyn supra flex., light red transl.

  • 616T112=4-2.5 ThermoLyn supra flexible, bordeaux

  • 616T112=4-3 ThermoLyn supra flexible, green

  • 616T112=4-3.4 ThermoLyn supra flexible, neon green

  • 616T112=4-4.1 ThermoLyn supra flexible, neon yellow

  • 616T112=4-5 ThermoLyn supra flexible, blue

  • 616T112=4-5.3 ThermoLyn supra flexible, light blue

  • 616T112=4-5.5 ThermoLyn supra flexible,dark blue trans

  • 616T112=4-6 ThermoLyn supra flexible, white

  • 616T112=4-7 ThermoLyn supra flexible, Black

  • 616T112=4-99 ThermoLyn supra flexible, Transparent

  • 616T112=400X400X12 ThermoLyn Supra Flexible Beige

  • 616T112=400X400X15 ThermoLyn Supra Flexible Beige

  • 616T112=400X400X6 ThermoLyn Supra Flexible Beige

  • 616T112=400X400X9 ThermoLyn Supra Flexible Beige

  • 616T112=40X40X5-7 ThermoLyn supra flexible, black

  • 616T112=5-0 ThermoLyn Supra Flexible Beige

  • 616T112=5-7 ThermoLyn supra flexible, black

  • 616T113=1.5-99 ThermoLyn supra flexible, transparent

  • 616T113=2-99 ThermoLyn supra flexible, transparent

  • 616T113=3-0 ThermoLyn Supra Flexible Beige

  • 616T113=3-99 ThermoLyn supra flexible, transparent

  • 616T113=4-0 ThermoLyn Supra Flexible Beige

  • 616T113=4-7 ThermoLyn supra flexible, black

  • 616T113=4-99 ThermoLyn supra flexible, transparent

  • 616T113=5-0 ThermoLyn Supra Flexible Beige

  • 616T113=5-7 ThermoLyn supra flexible, black 5M roll

  • 616T113=5-99 ThermoLyn supra flexible, transparent 5M

  • 616T120=2 ThermoLyn PP Copolymer natural

  • 616T120=3 ThermoLyn PP Copolymer natural 3mm

  • 616T120=3-8 ThermoLyn PP Copolymer, brown

  • 616T120=4 ThermoLyn PP Copolymer natural 4mm

  • 616T120=5 ThermoLyn PP Copolymer natural

  • 616T120=5-8 ThermoLyn PP Copolymer, brown

  • 616T120=6 ThermoLyn PP Copolymer natural

  • 616T16=950X3 ThermoLyn RCH 1000

  • 616T16=950X6 ThermoLyn RCH 1000

  • 616T173=45X60X2.4 Orfit Eco R mini perforated

  • 616T173=90X60X3.2 Orfit Eco R mini perforated

  • 616T174=600X900X3 Orfibrace macro perforated

  • 616T176=45X60X3.2 Orfit Eco Regrind mini perforated

  • 616T177=60X90X3.2 Orfit Eco Regrind MACRO Perforation

  • 616T178=45X60X3.2 Orfit Eco Nat Mini

  • 616T183=3 ThermoLyn PETG clear

  • 616T183=5 ThermoLyn PETG clear

  • 616T19=3-0 ThermoLyn PE 200 Beige

  • 616T19=4-0 ThermoLyn PE 200 Beige

  • 616T19=5-0 ThermoLyn PE 200 Beige

  • 616T20=2000X10 ThermoLyn PP Homopolymer

  • 616T20=2000X12 ThermoLyn PP Homopolymer

  • 616T20=2000X15 ThermoLyn PP Homopolymer

  • 616T20=2000X2 ThermoLyn PP Homopolymer

  • 616T20=2000X3 ThermoLyn PP Homopolymer

  • 616T20=2000X4 ThermoLyn PP Homopolymer

  • 616T20=2000X5 ThermoLyn PP Homopolymer

  • 616T20=2000X6 ThermoLyn PP Homopolymer

  • 616T20=2000X8 ThermoLyn PP Homopolymer

  • 616T20=400X400X10 ThermoLyn PP Homopolymer

  • 616T20=400X400X12 ThermoLyn PP Homopolymer

  • 616T20=400X400X15 ThermoLyn PP Homopolymer

  • 616T200=12 ThermoLyn EVA/LDPE SilverShield natural

  • 616T200=16 ThermoLyn EVA/LDPE SilverShield natural

  • 616T200=6 ThermoLyn EVA/LDPE SilverShield natural

  • 616T200=9 ThermoLyn EVA/LDPE SilverShield natural

  • 616T21=3050X1400X4 Perspex

  • 616T22=1910X2H Thermolyn RCH 500 Beige

  • 616T22=1910X2N THERMOLYN® RCH 500, Natural colour

  • 616T22=1910X3G THERMOLYN® RCH 500, Graffiti

  • 616T22=1910X3H Thermolyn RCH 500 Beige

  • 616T22=1910X3N THERMOLYN® RCH 500, Natural colour

  • 616T22=1910X4G THERMOLYN® RCH 500, Graffiti

  • 616T22=1910X4H Thermolyn RCH 500 Beige

  • 616T22=1910X4N THERMOLYN® RCH 500, Natural colour

  • 616T22=1910X5G THERMOLYN® RCH 500, Graffiti

  • 616T22=1910X5H Thermolyn RCH 500 Beige

  • 616T22=1910X5N THERMOLYN® RCH 500, Natural colour

  • 616T22=1910X6N THERMOLYN® RCH 500, Natural colour

  • 616T22=1910X8N THERMOLYN® RCH 500, Natural colour

  • 616T22=950X2H Thermolyn RCH 500 Beige

  • 616T22=950X3H Thermolyn RCH 500 Beige

  • 616T22=950X3N THERMOLYN® RCH 500, Natural colour

  • 616T22=950X4H Thermolyn RCH 500 Beige

  • 616T22=950X4N THERMOLYN® RCH 500, Natural colour

  • 616T22=950X5H Thermolyn RCH 500 Beige

  • 616T22=950X5N THERMOLYN® RCH 500, Natural colour

  • 616T22=950X6N THERMOLYN® RCH 500, Natural colour

  • 616T25 Padding Material, Self-Adhesive

  • 616T252=10 Antibacterial ThermoLyn rigid

  • 616T252=12 Antibacterial ThermoLyn rigid

  • 616T252=15 Antibacterial ThermoLyn rigid

  • 616T252=600X600X12 Antibacterial ThermoLyn rigid

  • 616T252=600X600X15 Antibacterial ThermoLyn rigid

  • 616T253=10 Antibacterial ThermoLyn soft colorless

  • 616T253=12 Antibacterial ThermoLyn soft colorless

  • 616T253=15 Antibacterial ThermoLyn soft colorless

  • 616T253=8 Antibacterial ThermoLyn soft colorless

  • 616T269=10 Antibacterial ThermoLyn Soft, Beige

  • 616T269=12 Antibacterial ThermoLyn Soft, Beige

  • 616T269=6 Antibacterial ThermoLyn Soft, Beige

  • 616T269=8 Antibacterial ThermoLyn Soft, Beige

  • 616T283=10 Antibacterial ThermoLyn clear

  • 616T283=12 Antibacterial ThermoLyn clear

  • 616T283=15 Antibacterial ThermoLyn clear

  • 616T283=20 Antibacterial ThermoLyn clear

  • 616T283=8 Antibacterial ThermoLyn clear

  • 616T3=1 Thermolyn Trolen

  • 616T3=2 Thermolyn Trolen

  • 616T3=2000X1000X2 Thermolyn Trolen

  • 616T3=2000X1000X3 ThermoLyn Trolen

  • 616T3=40X32X2 Thermolyn Trolen

  • 616T3=650X30X2 Thermolyn Trolen

  • 616T420=3 Antibacterial ThermoLyn PP Homopolymer

  • 616T420=4 Antibacterial ThermoLyn PP Homopolymer

  • 616T420=5 Antibacterial ThermoLyn PP Homopolymer

  • 616T44=1910X2 ThermoLyn RCH 500

  • 616T44=1910X3 ThermoLyn RCH 500

  • 616T44=1910X4 ThermoLyn RCH 500

  • 616T44=950X3 ThermoLyn RCH 500

  • 616T44=950X4 ThermoLyn RCH 500

  • 616T44=950X5 ThermoLyn RCH 500

  • 616T483=3 Antibacterial ThermoLyn PETG clear

  • 616T483=5 Antibacterial ThermoLyn PETG clear

  • 616T495=10 Antibacterial ThermoLyn PE 200

  • 616T495=2 Antibacterial ThermoLyn PE 200

  • 616T495=3 Antibacterial ThermoLyn PE 200

  • 616T495=5 Antibacterial ThermoLyn PE 200

  • 616T495=8 Antibacterial ThermoLyn PE 200

  • 616T52=10 ThermoLyn, rigid

  • 616T52=12 ThermoLyn, rigid

  • 616T52=15 ThermoLyn, rigid

  • 616T52=15-SF ThermoLyn Stiff

  • 616T52=8 ThermoLyn, rigid

  • 616T53=10 ThermoLyn, Soft

  • 616T53=12 ThermoLyn, Soft

  • 616T53=1225X12 ThermoLyn Soft

  • 616T53=1225X15 ThermoLyn Soft

  • 616T53=1225X8 ThermoLyn Soft

  • 616T53=15 ThermoLyn Soft

  • 616T53=8 ThermoLyn Soft

  • 616T56=3 Thermolyn PP, Dark Brown

  • 616T56=4 Thermolyn PP, Dark Brown

  • 616T56=5 Thermolyn PP, Dark Brown

  • 616T56=6 Thermolyn PP, Dark Brown

  • 616T58=3 ThermoLyn PE 200

  • 616T58=4 ThermoLyn PE 200

  • 616T58=5 ThermoLyn PE 200

  • 616T58=6 ThermoLyn PE 200

  • 616T59=10 Thermolyn Supra Soft

  • 616T59=12 Thermolyn Supra Soft

  • 616T59=15 Thermolyn Supra Soft

  • 616T62=3 ThermoLyn PE 200

  • 616T62=4 ThermoLyn PE 200

  • 616T62=5 ThermoLyn PE 200

  • 616T62=6 ThermoLyn PE 200

  • 616T69=10 ThermoLyn soft Beige

  • 616T69=12 ThermoLyn soft Beige

  • 616T69=6 ThermoLyn soft Beige

  • 616T69=8 ThermoLyn soft Beige

  • 616T690=1225X10 ThermoLyn soft, black

  • 616T690=1225X12 ThermoLyn soft, black

  • 616T690=1225X15 ThermoLyn soft, black

  • 616T690=1225X8 ThermoLyn soft, black

  • 616T690=400X10 ThermoLyn soft, black

  • 616T690=400X12 ThermoLyn soft, black

  • 616T690=400X15 ThermoLyn soft, black

  • 616T690=400X8 ThermoLyn soft, black

  • 616T71=2050X1250X5 Macrolon

  • 616T73=FP60X43X1.6 Thermolyn Pedilon

  • 616T73=FP60X43X2 Thermolyn Pedilon

  • 616T73=GP60X43X2 ThermoLyn Pedilon

  • 616T73=GP60X45X3.2 Thermolyn Pedilon

  • 616T73=GP90X60X4 ThermoLyn Pedilon

  • 616T73=MP60X43X2 Thermolyn Pedilon

  • 616T73=MP60X45X2.5 ThermoLyn Pedilon

  • 616T73=MP60X45X3.2 Thermolyn Pedilon

  • 616T73=NP60X43X2 Thermolyn Pedilon

  • 616T73=NP90X60X3.2 Thermolyn Pedilon

  • 616T73=NP90X60X4 Thermolyn Pedilon

  • 616T75=4 Thermolyn PVC

  • 616T83=10 ThermoLyn® Clear

  • 616T83=12 ThermoLyn® Clear

  • 616T83=1250X1025X3 ThermoLyn® Clear

  • 616T83=1250X1025X4 ThermoLyn® Clear

  • 616T83=1250X1025X6 ThermoLyn® Clear

  • 616T83=15 ThermoLyn® Clear

  • 616T83=15SF ThermoLyn® Clear

  • 616T83=20 ThermoLyn® Clear

  • 616T83=8 ThermoLyn® Clear

  • 616T92=2000X10 Relax Foam

  • 616T92=2000X20 Relax Foam

  • 616T93=2000X10 Relax Foam, Grey

  • 616T93=2000X20 Relax Foam, Grey

  • 616T95=1-ST PE-HWST, natural extruded, Standardqual.

  • 616T95=10 ThermoLyn PE 200

  • 616T95=12 PE Sheet Material

  • 616T95=2 ThermoLyn PE 200

  • 616T95=2-ST PE-HWST,natur.col. extrud.stand.quality

  • 616T95=3 ThermoLyn PE 200

  • 616T95=3-ST PE-HWST,natur.col. extrud.stand.quality

  • 616T95=3000X5-ST PE-HWST,natur.col. extrud.stand.quality

  • 616T95=4 ThermoLyn PE 200

  • 616T95=4-ST PE-HWST,natur.col. extrud.stand.quality

  • 616T95=5 ThermoLyn PE 200

  • 616T95=5-ST PE-HWST,natur.col. extrud.stand.quality

  • 616T95=6 ThermoLyn PE 200

  • 616T95=8 ThermoLyn PE 200

  • 617S21=3 Plastazote, perforated,white colour

  • 617S21=4 Plastazote, perforated,white colour

  • 617S21=6 Plastazote, perforated,white colour

  • 617S3=H10 Pedilin Beige

  • 617S3=H2 Pedilin Beige

  • 617S3=H3 Pedilin Beige

  • 617S3=H4 Pedilin Beige

  • 617S3=H5 Pedilin Beige

  • 617S3=H6 Pedilin Beige

  • 617S3=H7 Pedilin Beige

  • 617S3=H8 Pedilin Beige

  • 617S3=W10 Pedilin, white

  • 617S3=W2 Pedilin, white

  • 617S3=W3 Pedilin, white

  • 617S3=W4 Pedilin, white

  • 617S3=W5 Pedilin, white

  • 617S3=W6 Pedilin, white

  • 617S3=W7 Pedilin, white

  • 617S3=W8 Pedilin, white

  • 617S6=H3 Pedilin, perforated

  • 617S6=H4 Pedilin, perforated

  • 617S6=H5 Pedilin, perforated

  • 617S6=H6 Pedilin, perforated

  • 617S6=W3 Pedilin, perforated

  • 617S6=W4 Pedilin, perforated,White Colour (Hard)

  • 617S6=W5 Pedilin, perforated,White Colour (Hard)

  • 617S6=W6 Pedilin, perforated

  • 617S63=10 Sheet Stock-10mmx9inx12in

  • 617S63=3 Sheet Stock-2.5mmx9inx12in

  • 617S63=5 Sheet Stock-5mmx9inx12in

  • 617S63=6 Sheet Stock-6mmx9inx12in

  • 617S63=8 Sheet Stock-8mmx9inx12in

  • 617S64=10 Sticky Sheet Stock-10mmx9inx12in

  • 617S64=3 Sticky Sheet Stock-2.5mmx9inx12in

  • 617S64=5 Sticky Sheet Stock-5mmx9inx12in

  • 617S64=6 Sticky Sheet Stock-6mmx9inx12in

  • 617S64=8 Sticky Sheet Stock-8mmx9inx12in

  • 617S65

  • 617S68=1.6-0 PPT, beige

  • 617S68=3.2-0 PPT, beige

  • 617S68=6.4-0 PPT, beige

  • 617S7=10 Plastazote, skin color

  • 617S7=12 Plastazote Beige

  • 617S7=15 Plastazote, skin color

  • 617S7=18 Plastazote Beige

  • 617S7=2 Plastazote, skin color

  • 617S7=20 Plastazote, skin color

  • 617S7=25 Plastazote Beige

  • 617S7=3 Plastazote Beige

  • 617S7=4 Plastazote Beige

  • 617S7=5 Plastazote, skin color

  • 617S7=6 Plastazote Beige

  • 617S7=7 Plastazote Beige

  • 617S7=8 Plastazote, skin color

Instruções de Uso e Arquivos(1)

THERMOLYN -MANUAL.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T1641316412/04/2022, 11:19Exp. 2284445225

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

Documentos Técnicos(1)

131153622731/03/2022

MATERIAL – Notificação de Dispositivo Médico Classe I

Publicado deferimento

Petição primária

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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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