Events

Alerta De Seguridad para Sterile thread with needles

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por Allure Korea Co., Ltd., Korea.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Número del evento
    3
  • Fecha
    2017-03-21
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    There is no data available from the manufacturer's authorized representative in the european economic area (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); batch / serial number not specified (does not meet the requirement of annex 1, paragraph 14.3.4 of the regulation); after checking the information in the european database of medical devices eudamed, it has been found that the medical devices contained in this consignment are not registered, nor has eudamed found data on the korean manufacturer allure korea co., ltd., korea, and its authorized representative in the european community (does not meet the requirement of paragraph 45 of the regulation) ).
  • Acción
    Do not allow to enter the Lithuanian market

Device

Sterile thread with needles

Manufacturer

Allure Korea Co., Ltd., Korea
  • Representante del fabricante
    JSC „Beauty House Aurum“
  • Source
    MH