International safety notice

Hemodialysis device

Brazil / Anvisa · BRA · Nov 18, 2016

Key facts

Title Hemodialysis device
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: BELLCO HEMODIALYSIS MACHINE ///Medical Product Model: FORMULA 2000, FORMULA 2000 PLUS, FORMULA PLUS and FORMULA THERAPY ANVISA registration number:80102510346///Risk class: III - High Risk/// Model(s) affected: All models mentioned above.
Manufacturer DETENTOR DO REGISTRO NO BRASIL AUTO SUTURE DO BRASIL LTDA CNPJ 01645409000128ENDEREÇO AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR 04675010 MUNICÍPIO SÃO PAULO UF SPTELEFONE DE CONTATO 11 21829200 FABRICANTEBELLCO SRL MIRANDOLA ITÁLIA
Models 80102510346
Date Nov 18, 2016
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data
  • 1–9 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

Browse all International device safety notices