Events

Alerta De Seguridad para Dental collagen membranes - Colo Gide GTR

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por Cologenesis Healthcare Pvt. Ltd., India.

¿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
    7
  • Fecha
    2018-10-19
  • 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
    Medical devices and their packaging do not bear the ce marking and the number of the notified body, which does not comply with the requirements of articles 38, 39 and 40 of the regulation. instructions for use not included in medical devices are not in compliance with the requirements of annex 1, paragraph 14.1 of the regulation. there is no data on the manufacturer's authorized representative in the european economic area for medical devices, which does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation.
  • Acción
    Do not allow to enter the Lithuanian market

Device

Dental collagen membranes - Colo Gide GTR

Manufacturer

Cologenesis Healthcare Pvt. Ltd., India
  • Representante del fabricante
    Individual
  • Source
    MH