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 goods are not labeled with any information (implants are packed in transparent plastic bags without labels), so their labeling does not meet the requirements of annex 1, paragraph 14 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
Test tubes (neither commercial packaging nor individual label) shall bear the ce marking of conformity and the number of the notified body, which does not comply with the requirements of points 60 and 61 of the ivd regulation; the name and address of the authorized representative in the european economic area are not specified, which is not in line with the requirement of annex 1, paragraph 13.4.1 of the ivd 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 on medical devices not in accordance with 14.3.4 of annex 1 to the regulation. requirements of subparagraph (a). the date on which the medical device may be used safely is not specified on the medical device, which is not in accordance with annex 1, paragraph 14.3.5. requirements of subparagraph (a). part of the medical device and its packaging do not bear the ce marking and the identification 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
Medical devices and their packaging shall not bear the identification number of the notified body, which does not comply with the requirements of article 40 of the regulation; the name of the manufacturer, its address and the manufacturer's authorized representative in the european economic area are not specified, which does not comply with the requirements of 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
Ivd medical devices, their packaging and instructions for use do not bear the ce marking, which does not meet the requirements of point 61 of the ivd regulation; the name and address of the authorized representative of the manufacturer of the ivd medical device in the european economic area is not specified, which does not meet the requirements of annex 1, paragraph 13.4.1 of the ivd 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 and its packaging do not bear the ce conformity marking and the identification number of the notified body, which does not comply with the requirements of articles 38, 39 and 40 of the regulation; there is no label on the medical device, which is not in accordance with annex 14.1 of the regulation. requirements; the name of the manufacturer, its address and the manufacturer's authorized representative in the european economic area are not specified, which does not comply with the requirements of annex 1, paragraph 14.3.1. the batch / serial number is not specified, which 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 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
The pneumatic massage apparatus and its packaging shall not bear the ce conformity marking and the identification number of the notified body, which does not comply with the requirements of paragraphs 38, 39 and 40 of the regulation; all information on the pneumatic massage apparatus, its packaging and instructions for use is provided in a language other than the european community, which does not comply with the provisions of article 4 (4) of council directive 93/42 / eec; the manufacturer's trade name is indicated on the medical device but does not include the address and the manufacturer's authorized representative in the european economic area, which does not comply with 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 pneumatic massage apparatus and its packaging shall not bear the ce conformity marking and the identification number of the notified body, which does not comply with the requirements of paragraphs 38, 39 and 40 of the regulation; all information on the pneumatic massage apparatus, its packaging and instructions for use is provided in a language other than the european community, which does not comply with the provisions of article 4 (4) of council directive 93/42 / eec; the manufacturer's trade name is indicated on the medical device but does not include the address and the manufacturer's authorized representative in the european economic area, which does not comply with 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 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
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
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
Medical devices do not bear the ce marking, which does not comply with the requirements of articles 38 and 39 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. medical device labels do not include the name of the manufacturer, its address and 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 special conditions for the storage and maintenance of medical devices, the special conditions of use, warnings and precautions are not specified, which do not comply with the requirements of 14.3.9, 14.3.10, 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
Medical devices bear the ce conformity marking but are not accompanied by the identification number of the notified body, which does not comply with the requirements of article 40 and annex 7, paragraph 5 of the regulation. medical devices do not include the manufacturer's address and there is no 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.
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
Container disinfection does not include the name and address of the manufacturer, the name and address of the manufacturer's authorized representative in the european economic area, the details of the authorized representative in neither the instructions for use nor the transport packaging - do not meet the requirements of annex 1, paragraph 14.3.1 of the regulation; batch / serial number not specified for container disinfection - not in accordance with annex 1, paragraph 14.3.4 of the regulation; manufacturer's instructions for use in the container for disinfection in english are indicated by the ce conformity marking, followed by the number of the notified body 0044. the container for disinfection is classified as class i medical devices and is not sterile and has no measuring function. in accordance with the requirements of the regulation, such medical devices shall only be labeled with the ce conformity marking without the number of the notified body. considering this, the instructions for use of container disinfection are marked in violation of the requirements of article 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
Medical devices do not bear the ce marking, which does not comply with the requirements of articles 38 and 39 of the regulation; there are no data on the manufacturer and the manufacturer's authorized representative in the european economic area, which does not comply with 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.
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
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
Medical devices do not bear 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).
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 name and address of the manufacturer of the medical device is not specified and the name and address of the manufacturer's authorized representative in the european economic area are not specified (not in compliance with the requirements of annex 1, paragraph 13.4.1 of the ivd regulation); the label provided on the medical device packaging indicates that the objective glass is coated with food or chemical substances, as well as the "see". instructions for use ', but not specified in the instructions for use, the instructions for use have not been included (not in compliance with the requirements of annex 1, points 13.4.2 and 13.1 of the ivd 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, 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, the manufacturer's authorized representative in the european economic area and the batch / serial number, which does not meet the requirements of annex 1, paragraphs 14.3.1 and 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
Packages of medical devices do not bear the ce conformity marking, which does not comply with the requirements of articles 38 and 39 of the regulation. all information on individual packaging of medical devices is available in a language other than the european community, which does not comply with article 4 (4) of council directive 93/42 / eec. there is no data on the manufacturer, the manufacturer's authorized representative in the european economic area and no batch / serial number, which does not meet the requirements of annex 1, paragraphs 14.3.1 and 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
Medical devices and their packaging are not marked with the ce conformity marking - do not comply with the requirements of articles 38 and 39 of the regulation; the name and address of the manufacturer of the medical device not indicated on the label and its authorized representative in the european economic area and its address - does not comply with the requirements of annex 1, paragraph 14.3.1 of the regulation; unspecified lot or serial number - not in accordance with the requirements of annex 1, paragraph 14.3.4 of the regulation.