Glucose

Fabricant

  • 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
    NIDFSINVIMA

559 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
  • Description du dispositif
    IVD Other
  • Manufacturer
  • Modèle / numéro de série
    ALANIN AMINOTRANSFERASE (ALT), reference OSR6X07, all batches. GLUCOSE-STAT, reference OSR6X40, all batches.
  • Description du dispositif
    QUANTITATIVE DETERMINATION OF RELATED ANALYTS, IN SAMPLES FROM THE HUMAN MOTION.
  • Manufacturer
  • Modèle / numéro de série
    MT20649-1, MT20649-2, MT22719- 1 and MT22719-2
  • Classification du dispositif
  • Description du dispositif
    It is a glucose monitoring device designed to identify trends and monitor patterns in people of two or more years with diabetes. It is designed to be used by patients in their own home and in health centers. It is an additional device that complements, but replaces, the information obtained from standard glucose monitoring devices to be used at home. It helps to detect episodes of hyperglycemia and hypoglycaemia, allowing to adjust the treatments of acute and chronic cases.
  • Manufacturer
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