Events

Avis De Sécurité sur CEKA-Preciline

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Alphadent NV.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-05-04
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    On 4 april 2016, alphadent nv decided to withdraw as a result of the withdrawal of the ce conformity certificate for alphadent medical devices. the withdrawal of the ce conformity certificate for alphadent medical devices issued by the notified body does not affect nemko's products and the safety of these medical devices is not compromised. this cancellation is due to a request sent to the notified body by alphadent nv on 13 september 2013 authority to terminate the contract between the company and the notified body. nemko responded to this request on 4 april 2016 and notified the company of the withdrawal of the relevant ce certificate of conformity.   alphadent nv is actively working with the newly notified body to obtain a new ce certificate of conformity for alphadent medical devices.

Device

CEKA-Preciline

Manufacturer

Alphadent NV