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Dispositivos MédicosCancelado

acessórios cortex

10307270013

Registro cancelado em 28/03/2022 segundo a ANVISA.

Informações Gerais

Nome do produto

acessórios cortex

Número de registro

10307270013

Classe de risco

I

Processo

25351459825202111

Empresa Detentora

País de fabricação

ALEMANHA

Registro

Situação

Cancelado

Vencimento

Vence em 7 dias04/11/2026
Histórico de Situação

Nenhuma mudança de situação registrada.

Apresentações / Modelos(75)

  • 0,68m Typ C

  • 000-40-010 - USB cable

  • 000-45-016 - O2 Sensor OOM109-C for MetaMax 3B/3X

  • 000-45-020 - O2 Sensor, vacuum-sealed for MetaLyzer 3B/MetaLyzer II

  • 000-45-037 - Smart HR sensor set H10

  • 010-00-001 - Pediatric/Adult face mask adaptor for Cortex flow sensor

  • 010-00-005 - Calibration gas bottle, 1 litre

  • 010-00-012 - Pediatric head cap assembly, small

  • 010-00-019 - Pediatric face mask, small

  • 010-00-020 - Pediatric face mask, large

  • 010-00-021 - Pediatric head cap assembly, large

  • 010-00-026 - Nose clip (reusable) metal torsion spring design

  • 010-00-050 - Face mask large dark-blue

  • 010-00-051 - Face mask medium dark blue

  • 010-00-052 - Face mask small dark blue

  • 010-00-053 - Face mask extra small

  • 010-00-054 - Face mask petite

  • 010-00-055 - Head cap assembly for face mask extra small + petite

  • 010-00-056 - Head cap assembly for face mask small + medium

  • 010-00-057 - Head cap assembly for face mask large

  • 010-00-059 - Medium face mask brace set

  • 010-00-061 - Small face mask brace set

  • 010-00-062 - Easy Release Clips

  • 010-00-063 - Easy Release Clips black for dark blue mask set with red head cap assembly

  • 010-00-064 - Large face mask brace set

  • 010-00-065 - Extra small face mask brace set

  • 010-00-066 - Petite face mask brace set

  • 010-00-083 - Calibration syringe 3 litres

  • 010-00-101 - Pediatric/Adult face mask adaptor for Cortex flow sensor with disposable turbine

  • 010-00-103 - Adapter for volume flow sensor for spirometry handle

  • 010-00-104 - Autoclavable mask adapter

  • 010-00-105 - Mask adapter for bacteria & virus filter (BVF)

  • 010-00-106 - BVF-adapter for disposable turbine

  • 010-00-107 - BVF-adapter for reusable turbine

  • 010-01-550 - Cortex disposable

  • 010-01-791 - Calibration kit professional without carrying case

  • 010-01-792 - Calibration kit professional with carrying case without gas

  • 010-01-793 - Calibration kit professional

  • 010-01-897 - Tube adaptor Gas-on-demand for non-CORTEX gas bottles

  • 010-01-898 - Gas-on-demand-valve with adaptor for CORTEX gas bottle

  • 010-15-103 - O-ring (green) for CORTEX volume flow sensor electronic with disposable turbine

  • 010-15-104 - O-ring (black) for mask adaptor for CORTEX volume flow sensor with disposable turbine

  • 010-70-001 - Carrying case calibration kit

  • 1,40 m

  • 130-00-013 - Back carrying system for Metamax 3B

  • 130-01-015 - Sample line for MetaMax 3B 60cm

  • 130-01-022 - Extension cable for volume flow sensor 1,40 m

  • 130-01-032 - Volume flow sensor complete 0,6 m

  • 130-01-033 - Electronic assembly with cable and temperature sensor 0,6m

  • 130-01-090 - Connection cable, serial PC

  • 131-01-051 - Connection cable PC USB – Telemetry

  • 136-00-002 - Earphone with cable MetaMax

  • 136-00-011 - MaxSport Jacket small with integrated battery pouch

  • 136-00-012 - MaxSport Jacket large with integrated battery pouch

  • 136-01-002 - Volume flow sensor, complete

  • 136-01-007 - Electronic assembly with cable and temperature sensor 0,6m

  • 136-01-015 - Sample line for MetaMax 3B

  • 136-01-020 - Cortex volume flow sensor with disposable turbine Metamax 3B

  • 136-01-021 - Cortex electronic for volume flow sensor with disposable turbine Metamax

  • 136-01-026 - Sample line for Sample Flow Dryer MetaMax 3B

  • 136-01-061 - GPS Receiver (Metamax 3B)

  • 136-01-081 - Sample Flow Dryer MetaMax 3B

  • 136-60-010 - Extension cable for volume flow sensor, stationary

  • 136-70-013 - Carrying case MetaMax

  • 200-01-017 - Volume flow sensor with temperature sensor for Metalyzer 3B, Metalyzer II

  • 200-01-018 - Electronic assembly with temperature sensor for Metalyzer 3B, Metalyzer II

  • 200-01-020 - Cortex Volume flow sensor with disposable turbine 200-01-090 - Connection cable, serial PC

  • 200-01-160 - Sample line for MetaLyzer 3B

  • 220-02-003 - Sample line for MetaLyzer 3B

  • 220-70-001 - Carrying case Metalyzer 3B

  • 23

  • 236-01-011 - Volume flow sensor with temperature sensor for Metalyzer 3B, 2m

  • 236-01-013 - Electronic assembly with temperature sensor 2m

  • dark blue

  • dark blue

Documentos Técnicos(2)

392867521404/11/2021

MATERIAL – Notificação de Dispositivo Médico Classe I

Publicado deferimento

Petição primária
016894222810/02/2022

MATERIAL – Alteração de notificação – Implementação imediata

Publicado deferimento

Produtos relacionados

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