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 do not bear the ce marking (does not meet the requirements of points 38 and 39 of the regulation); the packaging of the medical device is indicated by an authorized representative of emergo europe bv (the netherlands), and the authorized representative of the manufacturer in the customs documentation is designated by unimedica ltd (bulgaria). a manufacturer who places medical devices on the market in his own name and has no registered office in the european economic area must appoint one authorized representative in the european economic area (not in compliance with the requirements of article 45 of the regulation).
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
Neither the outer packaging of the medical device nor the medical device itself bear the ce conformity marking (does not meet the requirements of mn 4: 2009 38 and 39); no data are available anywhere on the manufacturer of the items in the consignment and on the manufacturer's authorized representative in the european economic area (not in compliance with mn 4: 2009, annex 1, clause 14.3.1); no batch / serial number anywhere (does not meet mn 4: 2009, annex 1, clause 14.3.4); there is no information necessary to identify medical devices and contents of packages (does not meet the requirements of mn 4: 2009 annex 1 clause 14.3.2).