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 mp bears no ce marking (does not meet the requirements of mn 4: 2009 38); name and address of the manufacturer not specified (not in accordance with mn 4: 2009, annex 1, paragraph 14.3.1); the name and address of the authorized representative in the european economic area not specified (does not meet the requirements of 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); conditions for the maintenance (sterilization) of a non-specified medical device (not in compliance with mn 4: 2009, annex 1, paragraph 14.3.9); special conditions of use for non-specified medical device (not in accordance with mn 4: 2009 annex 1 clause 14.3.10).
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 mp bears no ce marking (does not meet the requirements of mn 4: 2009 38); name and address of the manufacturer not specified (not in accordance with mn 4: 2009, annex 1, paragraph 14.3.1); the name and address of the authorized representative in the european economic area not specified (does not meet the requirements of 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); conditions for the maintenance (sterilization) of a non-specified medical device (not in compliance with mn 4: 2009, annex 1, paragraph 14.3.9); conditions of use of a non-specified medical device (not in compliance with mn 4: 2009, annex 1, paragraph 14.3.10).
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 instructions for use contain 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
The sales packaging does not bear the ce conformity marking and the notified body no. neither the medical devices themselves nor the sales packaging of medical devices nor the instructions for use contain 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
The individual packaging of the mp does not bear the ce conformity marking and the notified body no. (does not meet the requirements of mn 4: 2009 38, 39, 40). the manufacturer's address and the manufacturer's authorized representative in the european economic area (hereinafter referred to as the 'authorized representative' in the eea) are not specified anywhere (not in compliance with mn 4: 2009, annex 1, paragraph 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
Medical devices are not accompanied by instructions for use, medical device information is provided in a language other than the european community, so the information provided on the labels 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
The individual packaging of the medical devices included in the first aid kit does not bear the ce conformity marking, the sterile medical device packages do not include the notified body no. there is no data on the manufacturer's authorized representative in the european economic area. individual packagings for blood stopping for individual packing are not marked with ce marking and notified body no; no data on manufacturer's authorized representative in the european economic area. eye clean sterile eye wash liquid unlabeled ce mark and notified body no; there is no data on an 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
Medical devices and their packaging do not bear the ce conformity marking, which does not comply with the requirements of articles 38 and 39 of the regulation; neither medical devices nor their packaging contain data on the manufacturer's authorized representative in the european economic area, which does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation; the batch / serial number is not specified, which does not meet the requirements of annex 1, paragraph 14.3.4 of the regulation; neither medical devices nor their packaging indicate any special medical device maintenance, use conditions, and warnings and / or precautions, which do not comply with annex 1, paragraph 14.3.9 of the regulation. - 14.3.11. requirements of sub-paragraphs.
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 are not affixed with the ce marking and the number of the notified body (not in accordance with the requirements of articles 38, 39 and 40 of the regulation); the label of the medical device does not contain information on 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).
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 are not affixed with the ce marking and the number of the notified body (not in accordance with the requirements of articles 38, 39 and 40 of the regulation); medical devices do not have an authorized representative of the data manufacturer in the european economic area (does not meet the requirements of annex 1, paragraph 14.3.1 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
Medical devices do not bear the ce marking (does not meet the requirements of points 38 and 39 of the regulation); medical device manufacturer's authorized representative in the european economic area not covered by the medical device label (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); batch code or serial number of the medical device not indicated on the label of the medical device (does not meet the requirements of annex 1, paragraph 14.3.4 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
The individual packaging of medical devices bears the ce conformity marking, but does not have a notified body number; there is no manufacturer's address, no data on an authorized representative in the european economic area. no information is available on the safe use of the medical device.
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
On the label of the medical device, on the outer packaging, the instructions for use do not contain information on the manufacturer's authorized representative in the european economic area and the address of the manufacturer is not specified (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); the instrument and its packaging do not mark the ce conformity marking (does not comply with the requirements of article 38 of the regulation), the intended use of the product is not specified in the package leaflet, contraindications (does not comply with the requirements of annex 1, paragraph 14.6 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
Medical devices and labels do not bear the ce conformity marking and the number of the notified body (not in compliance with points 38, 39 and 40 of the regulation); there are no instructions for use attached to medical devices (not in compliance with clause 14.1 of annex 1 to the regulation); the medical device labels do not contain information on the manufacturer's authorized representative in the european economic area (not in compliance with annex 1, paragraph 14.3.1 of the regulation); method of sterilization of medical devices not indicated on the labels of medical devices (does not comply with point 14.3.10 of annex 1 to the regulation); the batch number of 135 ° on the hip plate with 3 holes (not in accordance with annex 1, paragraph 14.5 of the regulation); labeled by vigor ortho (india). after checking the information in the eudamed, such a manufacturer is not registered.
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 orthopedic screws in the bundle are packed in plastic bags with a label affixed to them. no additional information on these propellers or their use has been added to the packaging. the label shows the manufacturer of the medical device: vigor ortho (india) but does not specify the manufacturer's authorized representative in the european community (does not meet the requirement of annex 1, paragraph 14.3.1 of the regulation); the label states that the medical device is placed on the market non-sterile but does not provide information on how this medical device should be sterilized before its intended use (implantation) (does not meet the requirement of annex 1, paragraph 14.3.10 of the regulation); eudamed, the european database for medical devices, has no information on the manufacturer vigor ortho (india), and there is no information that this manufacturer will be issued with a certificate of compliance with the requirements of the council directive 93/42 / eec on medical devices. commodities are ce marked with the number of the notified body 2107. the list of notified bodies of existing medical devices published by the european commission in the notified bodies of the european commission does not include the notified body number 2107 (does not meet the requirements of article 40 of the regulation).
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding the use of the device. 3rd Party Publications
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).
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding a software upgrade. 3rd Party Publications
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding a device removal. 3rd Party Publications
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding a device removal. 3rd Party Publications
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding a software upgrade. 3rd Party Publications
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding the use of the device. 3rd Party Publications
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding changes/updates made to instructions for use. 3rd Party Publications
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding a software upgrade. 3rd Party Publications