Inpeco SA

3 dispositifs dans la base de données

  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostics - instruments, apparatuses and systems
  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostics - equipment / products for clinical chemistry
  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostics - equipment / products for clinical chemistry

5 fabricants avec un nom similaire

En savoir plus sur les données ici

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA