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 on the manufacturer on the inner pack of the mp (does not meet the requirements of mn 4: 2009 annex 1, clause 14.3.1). the number of the notified body is not indicated on the labels of medical devices (does not meet the requirements of mn 4: 2009 40).
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
Tooth-sealing materials filtek z250 does not bear the ce conformity marking and the notified body no. (does not meet the requirements of mn 4: 2009 38, 39 and 40). there is no notified body number on the outer packaging (does not meet the requirements of mn 4: 2009 40). there is no data available for an authorized representative in the european economic area (does not meet the requirements of mn 4: 2009 annex 1 clause 14.3.1).
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
1. there is no information necessary to identify the medical device and the contents of the packaging (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.2). 2. the ce marking and the number of the notified body shall not be affixed to the medical device or to the packaging of the medical device (not in accordance with mn 4: 2009 38, 39 and 40). 3. there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area (not in compliance with mn 4: 2009, annex 1, clause 14.3.1). 4. no model, batch / serial number (does not meet mn 4: 2009 requirements 14.3.4). 5. no information is available on the safe and proper use of the medical device (not in accordance with mn 4: 2009 annex 1, clause 14.1).
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
The in vitro diagnostic medical device is not affixed with the ce conformity marking and the notified body no. (does not meet the requirements of mn 102: 2001 64, item 65), there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area (does not meet the requirements of mn 102: 2001 annex 1, clause 13.4.1), no instructions for use (not in accordance with mn 102: 2001 annex 1 13.4.9).
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
The in vitro diagnostic medical device is not affixed with the ce conformity marking and the notified body no. (does not meet the requirements of mn 102: 2001 64, item 65), there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area (does not meet the requirements of mn 102: 2001 annex 1, clause 13.4.1), no instructions for use (not in accordance with mn 102: 2001 annex 1 13.4.9). the packaging of the appliance, nor the instructions for use, does not bear the ce conformity marking and the number of the notified body (does not comply with the requirements of mn 102: 2001 64, 65), there is no data on the manufacturer's authorized representative in the european economic area (not in compliance with mn 102: 2001 annex 1 clause 13.4.1) requirements).
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
In vitro diagnostic medical device unmarked with ce conformity marking (not in compliance with mn 102: 2001 64, item 65), no data on manufacturer and manufacturer's authorized representative in the european economic area (not in compliance with mn 102: 2001 annex 1 clause 13.4.1) , there is no inscription on the use of the device in vitro (does not meet the requirements of mn 102: 2001, annex 1, clause 13.4.7), there is no data on special storage conditions (does not meet the requirements of mn 102: 2001 annex 1, clause 13.4.7), no instructions for use (does not meet mn 102: 2001 annex 13, section 13.4.9).
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 instructions for use nor the packaging bear the ce conformity marking, no data are available on the manufacturer's authorized representative in the european economic area.
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 instructions for use nor the packaging bear the ce conformity marking. there is no information on the manufacturer on the medical device or on the packaging of the product, and there is no data on the manufacturer's authorized representative in the european economic area. it is necessary to identify the medical device on the medical device, which is not specified on the medical device itself. the medical device packaging does not include the serial no.
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 about the manufacturer and the manufacturer's authorized representative in the european economic area, no information required to identify the medical device and the contents of the packaging.
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
Conformity marking ce and notified body no. 0297 and 1252 are used illegally.
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 on the manufacturer and the manufacturer's authorized representative in the european economic area (does not meet the requirements of mn 4: 2009, annex 1, clause 14.3.1), the operating instructions do not bear the ce marking and the number of the notified body (does not meet the requirements of mn 4: 2009 38 and 40) ).
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 medical devices nor the outer packaging bear the ce marking and the number of the notified body; no data on manufacturer's authorized representative in the european economic area.
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
Packages of medical devices do not bear the ce conformity marking, there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area, there is no batch / serial number, no information is available on the relevant processes that can be used again for medical devices, including cleaning, disinfection and packaging. and, if necessary, re-sterilizing the medical device and how many times the medical devices can be reused.
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 conformity marking, the manufacturer and the manufacturer's authorized representative in the european economic area, no batch / serial number, no date (year and month) for safe use of medical devices.
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
The medical device itself is marked with the trademark "ortogama", but there is no manufacturer's address anywhere, there is no data on the manufacturer's authorized representative in the european economic area, no model, no batch / serial number; medical device labels are labeled with a ce marking.
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
Packages of medical devices do not bear the ce conformity marking; the trade name is indicated but the address of the manufacturer is not indicated; there is no data on the manufacturer's authorized representative in the european economic area; no batch / serial number.
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
Packages of medical devices do not bear the ce conformity marking; the trade name is indicated but the address of the manufacturer is not indicated; there is no data on the manufacturer's authorized representative in the european economic area; no batch / serial number.
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 medical devices themselves nor the packaging of medical devices bear the ce conformity marking, there is no data on the manufacturer, the manufacturer's authorized representative in the european economic area, no batch / serial number.
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
Do not affix the ce marking and the number of the notified body; no batch / serial number.
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 medical device itself, nor the outer packaging, nor the instructions for use of the medical device, bear the ce marking and the number of the notified body on the medical device or on the packaging of the medical device nor the instructions for use of the device and the manufacturer's authorized representative in the european economic area. ; no batch / serial number.
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
The outer packaging and the instructions for use of the medical device do not mark the ce conformity marking and the number of the notified body, the medical device itself is not marked with the number of the notified body.
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
Labels on all medical devices in the consignment are labeled "sterile", labeled with medical devices, and ce marked with the medical devices themselves, but no published body number. individual packages of medical devices do not guarantee the sterility of medical devices. there is no information on safe and proper use of medical devices.
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
The outer packaging does not bear the ce conformity marking. there is no data about the manufacturer and the manufacturer's authorized representative in the european economic area. no batch / serial number.
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
The outer packaging does not bear the ce conformity marking. there is no data about the manufacturer and the manufacturer's authorized representative in the european economic area. no batch / serial number.
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 instructions for use of the medical device bear the ce marking and the number of the notified body. the label of the medical device bears the ce marking of conformity, but there is no notified body number.