External Fixators - ANVISA Registration 80012450036
Access comprehensive regulatory information for External Fixators in Brazil's medical device market through Pure Global AI's free database. This Risk Class I medical device is registered under ANVISA number 80012450036 and manufactured by RESPONSE ORTHO LLC. The registration is held by BIOSINTESE HOSPITALAR LTDA with validity until currently active (VIGENTE).
This page provides complete technical specifications for this device, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including G D RUFINO LTDA EPP, CPMH - Comércio e Indústria de Produtos Médico-Hospitalares e Odontológicos LTDA., and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.

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Registration Details
80012450036
25351260720201533
01086229000153
Company Information
Dates and Status
Nov 23, 2015
VIGENTE
09/18/2025 19:00:01
External Fixation System
Sistema de fixadores externos para membros superiores - Unix Wrist/Elbow
RESPONSE ORTHO TEKNOLOJIK URETIM A S
80312580003
Oct 24, 2019
External Fixation System
SISTEMA DE FIXAÇÃO EXTERNOS UNIX BAR
RESPONSE ORTHO TEKNOLOJIK URETIM A S
80312580004
Oct 24, 2019
External Fixation System
FIXADORES EXTERNOS UniX MULTIARTICULADOS
RESPONSE ORTHO LLC
80012450033
Jun 01, 2015
External Fixation System
FIXADORES EXTERNOS UNIX RAIL
RESPONSE ORTHO LLC
80012450029
Dec 16, 2013
External Fixation System
FIXADORES EXTERNOS UNIX RAIL
Tuna medikal Urunler Paz.ltd.Sti.
80012450029
Dec 16, 2013
G D RUFINO LTDA EPP• Brazil
CPMH - Comércio e Indústria de Produtos Médico-Hospitalares e Odontológicos LTDA.• Brazil
AIKE (SHANGHAI) MEDICAL INSTRUMENT CO., LTD• China
ORTHOFIX SRL• Italy
SUZHOU SUNAN ZIMMERED MEDICAL INSTRUMENT CO., LTD• China
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ALPHA OMEGA ENGINEERING LTD.
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XIAMEN DELANGGE MEDICAL TECHNOLOGY CO., LTD.,
81504790507
Sep 01, 2025
Fixadores Externos
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S V SAUDE LTDA
83206250001
Sep 01, 2025
Fixadores Externos
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ROSS USINAGEM LTDA
82449260024
Aug 25, 2025