French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
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At the request of the Afssaps and following an inspection, the 3S Medikal Laboratory withdraws from the market the 030825 batch of the medical device called blepharostat following the absence of CE marking of conformity and validation of the sterilization. These devices are distributed by the PRODIS company which will directly inform the users of this lot.