International safety notice

Technical name: Self-test for Coagulation parameters

Brazil / Anvisa · BRA · Sep 21, 2016

Key facts

Title Technical name: Self-test for Coagulation parameters
Regulator Brazil / Anvisa
Country BRA
Brand Commercial name: InRatio 2 Monitoring System Technical name: Self-test for Coagulation parameters ANVISA registration number: 10071770848 Risk class: III Affected model: InRatio2 Pro Monitor / InRatio2 Monitor
Manufacturer EMPRESA DETENTORA DO REGISTRO ALERE SA ENDEREÇO RUA DOS PINHEIROS 498 SÉTIMO ANDAR PINHEIROS SP TELEFONE 0800 113363 FABRICANTE ALERE SAN DIEGO INC 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121
Models 10071770848, InRatio2
Date Sep 21, 2016
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 100–999 Matching device models in FDA data
  • 100–999 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

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