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 does not bear the ce marking, which does not comply with the requirements of articles 38 and 39 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
There is no data about the manufacturer and the manufacturer's authorized representative in the european economic area. the label of the medical device bears the ce conformity marking, but does not include 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 marking of conformity, but there is no notified body 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
No manufacturer, authorized representative, no ce mark and no notified body 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
There is no data on the manufacturer and the manufacturer's authorized representative in the european economic area, there is no "ce mark and notified body number, no instructions for use.
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
The labels on the packaging indicate the manufacturer's trade mark, but do not include the manufacturer's address, no data on the authorized representative in the european economic area. there is no information on the 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 address of the manufacturer is not indicated on the packaging of blood lancets, no medical devices expired on 14.12.2014 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 outer packaging of the medical device nor the medical device itself, nor the instructions for use, shall bear the ce marking and the number of the notified body. there is no data about the manufacturer and the manufacturer's authorized representative in the eea. 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 medical device does 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. the name and address of the manufacturer's authorized representative in the european economic area are not specified, which does not correspond to section 14.3.1. requirements of subparagraph (a).
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
Batch / serial number not specified anywhere (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.4).
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 (labels) of medical devices are marked with the symbol "see instructions for use", but the instructions for use are not included (not in accordance with the requirements of annex 1, paragraph 14.1 of the regulation); medical device labels do not specify any special medical device care conditions, warnings, and / or precautions (and do not meet the requirements of 14.1.9 - 14.3.11 of annex 1 to 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
Batch / serial number not specified anywhere (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.4).
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 batch / serial number specified (does not meet mn 4: 2009, annex 1, clause 14.3.4). it should be noted that medical devices are not transported in commercial packages that are added separately.
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.
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 label does not include a batch / serial number that 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
There is no ce mark, no mandatory information on the label.
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 available from 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); batch / serial number not specified (does not meet the requirement of annex 1, paragraph 14.3.4 of the regulation); after checking the information in the european database of medical devices eudamed, it has been found that the medical devices contained in this consignment are not registered, nor has eudamed found data on the korean manufacturer allure korea co., ltd., korea, and its authorized representative in the european community (does not meet the requirement of paragraph 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
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); after checking the information in the european database of medical devices eudamed, the medical devices contained in this consignment were found not to be registered. eudamed has not found any chinese manufacturer alton (shanghai) medical instruments co., ltd., china, and its authorized representative in the european community (does not meet the requirements of paragraph 45 of the regulation); the label indicates that the medical device is non-sterile and reusable, but the method of sterilization is not specified (does not meet the requirements of annex 1, paragraph 14.3.13 of the regulation). the instructions for use are not included, no label or symbol on the label, instructions for use attached.
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 instructions for use do not bear the ce conformity marking. there is no data available for 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
The medical device does 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.
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
All instructions for use attached to the ivd tests do not bear the ce conformity marking - do not meet the requirements of point 61 of the ivd regulation; name and address of the manufacturer's authorized representative in the european economic area not specified in the package leaflet accompanying the ivd tests peanut allergy test device, dust mite test device, outer packaging and individual test packaging - not in accordance with annex 1, 13.4.1 of the ivd regulation requirements; lancets in ivd diagnostic test kits for finger puncture and blood sampling for ivd testing, without ce marking, no manufacturer and address, no manufacturer's authorized representative in the european economic area, no batch / serial number, non-sterile medical device (unpacked) it is not possible to separate the lancet according to the lancet structure in a separate package to ensure sterility, lancet has not been used), no information has been added that it should be sterilized before use of the lancet and no indication is given that the measure is intended for single use. can be safely used - does not meet the requirements of mp 39 and annex 1, paragraph 9, 14.3.1, 14.3.3, 14.3.4, 14.3.5, 14.3.614.3.10.
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 individual packaging of medical devices does not indicate that the medical device is sterile (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.3); no individual batch / serial number on the individual packaging of medical devices (does not meet the requirements of mn 4: 2009 annex 1, clause 14.3.4); the individual packaging of medical devices does not indicate the date by which the medical devices can be used safely (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.5); there is no data available for an authorized representative in the european economic area (hereinafter referred to as "authorized representative in the eea") (does not meet the requirements of mn 4: 2009 annex 1 clause 14.3.1). please note that not all information on outer packagings and individual packs of medical devices is available in the european community language and therefore some information is not identifiable, the information in the leaflets accompanying the medical device is not in the european community language (does not comply with article 4 of council directive 93/42 / eec). (see point 4).
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 (labels) of medical devices do not bear the ce conformity marking and the number of the notified body (not in accordance with the requirements of points 38 and 40 of the regulation).