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
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
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
The label of the medical device bears the ce conformity marking but does not bear the number of the notified body, the ce marking of the medical device does not bear the ce marking and the number of the notified body. the manufacturer of the medical device is only mentioned on the label of the medical device, there is no information about the authorized representative in the eea anywhere.
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 label of the medical device bears the ce conformity marking, but does not include the number of the notified body. the manufacturer of the medical device is only mentioned on the label of the medical device, but there is no manufacturer's address, there is no information about the authorized representative in the eea anywhere. the instructions for use of the medical device do not bear the ce marking and 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
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 conformity marking, but does not include the number of the notified body. the manufacturer is listed, but no manufacturer's address is given, there is no information about the manufacturer's authorized representative in the eea. the manufacturer's instructions do not contain any data on the manufacturer.
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
No data on manufacturer, authorized representative, pulse oximeter and instructions for use indicate ce marking and no notified body 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
Packages of medical devices are not marked with the number of the notified body; no data on the manufacturer and 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 medical devices nor their packaging bear the ce conformity marking; neither the medical device itself nor its packaging contains data on the manufacturer and the authorized representative.
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 devices themselves and their instructions for use do not bear the ce conformity marking, neither the medical devices themselves nor the instructions for use contain information on the manufacturer, authorized representative, batch / serial number, model and date of manufacture of the medical devices themselves.
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, medical devices themselves and instructions for use shall not bear the ce marking and the notified body 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 on the manufacturer and the manufacturer's authorized representative in the european economic area. the number of the notified body is not indicated. no information is available on the safe and proper use of medical devices. labels for medical devices are labeled with a ce marking that does not comply.
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 medical devices nor the individual packaging of medical devices nor the instructions for use of medical devices bear the ce conformity marking and the number of the notified body. medical device information and instructions for use are provided in a language other than the european community, so the information provided on the labels and instructions for use of medical devices cannot be identified.
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
Packagings of micro-scalers are not marked with the ce conformity marking there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area and no batch / serial number is given.
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 packaging of the drill holders nor the drill holders themselves mark the ce conformity marking. there is no data on the manufacturer and the manufacturer's authorized representative in the european economy and no batch / serial number is given.
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
Bone drilling machines and their instructions for use in dentistry do not bear the ce marking and do not indicate the number of the notified body. neither the medical devices themselves nor the instructions for use contain data on the manufacturer and the manufacturer's authorized representative in the european economic area. there are no batch / serial numbers and date of manufacture on the medical devices themselves.
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
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
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
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
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
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, 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.