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 external batch / serial number specified (does not meet mn 4: 2009, annex 1, clause 14.3.4). the medical device label does not contain information on the purpose of the medical device and the contents of the packaging (does not meet the requirements of mn 4: 2009 annex 1, clause 14.3.2).
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 bear the ce conformity marking (does not meet the requirements of mn 4: 2009 38 and 39). no model specified, batch / serial number (does not meet mn 4: 2009, annex 1, clause 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
The outside packaging of the mp does not include the manufacturer's authorized representative in the european economic area (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.1). the individual packages of articulation paper do not bear the ce conformity marking (not in accordance with mn 4: 2009 item 38). batch / serial number not specified (not in compliance with mn 4: 2009, annex 1, clause 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 anywhere (does not meet mn 4: 2009, annex 1, clause 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
The mp does not bear the ce conformity marking and does not indicate the number of the notified body (does not meet the requirements of mn 4: 2009 38, 39 and 40). the number of the notified body is not indicated on the outer packaging of the medical device (does not meet the requirements of mn 4: 2009, item 40). batch / serial number not specified (not in compliance with mn 4: 2009, annex 1, clause 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
In vitro diagnostic medical devices (devices) with unmarked ce marking (not in compliance with point 60 of the regulation), no data on manufacturer's authorized representative in the european economic area (not in compliance with the requirements of annex 1 paragraph 13.4.1 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
There is no data on the manufacturer's authorized representative in the eea.
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 on the medical device packaging is labeled by the manufacturer but does not include the manufacturer's address, and there is no data on the manufacturer's authorized representative in the european economic area. no batch / serial number. packages of medical devices are marked with a ce conformity 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
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
There is no data on the manufacturer's authorized representative in the european economic area. no information is available 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
Medical device labels do not contain data on the authorized representative in the european economic area, which does not meet the requirement 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
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
Neither the do2-5ah oxygen concentrators nor the instructions for use indicate the ce conformity marking and the notified body no; neither the medical device itself 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
Neither on the outer packaging nor on the label nor in the instructions for use, an authorized representative of the european economic area (not in compliance with subparagraph 14.3.1 of annex 1 to the regulation); neither the ce marking nor the number of the notified body appear on the outer packaging, nor on the label or in the instructions for use (does not comply with points 38, 39 and 40 of the regulation). in addition to the ce conformity marking, the number of the notified body is not indicated (does not correspond to point 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
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
Mixing vessels do not label the ce conformity marking. there is 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
The ce marking is not affixed to the plastic endodontic lenses or to the medical devices themselves. there is 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
No single sterile suction pack or individual medical device packaging bears the ce conformity marking and the notified body no. there is no data 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 outer packaging of the temporary fillers, nor the medical devices themselves, nor the instructions for use indicate the ce conformity marking and the notified body no. . neither medical devices nor packaging nor instructions for use contain data 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
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).
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
There is no data on the manufacturer, no instructions for use, labels for medical devices bear the ce marking not complying with the requirements of mn 4: 2009 annex 12.
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 (not in compliance with the requirement of article 38 of the regulation); there is no information on the manufacturer's authorized representative in the european economic area on the label and in the instructions for use of the medical device (does not meet the requirements of annex 1, paragraphs 14.3.1 and 14.6.1 of the regulation); batch / serial number not indicated on the label of the medical device (does not meet the requirement of annex 1, paragraph 14.3.4 of the regulation); conditions for the storage and / or maintenance of a medical device not mentioned in the label and instructions for use of the medical device (for example, it does not specify the means to be cleaned and disinfected by these chairs) (does not comply with point 14.3.9 of annex 1 to the regulation); after checking the eu database of medical devices eudamed and the lithuanian medical devices information system mepris, no information was found about the mobile folding blood donor seats md 2500 and their manufacturer mobile designs inc., usa.
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 and the notified body no. there is 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
Medical devices do not bear the ce conformity marking (not in compliance with mn 4: 2009 item 38); there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area (hereinafter referred to as the authorized representative in the eea) (does not meet the requirements of mn 4: 2009 annex 1 clause 14.3.1); no batch / serial number (does not meet mn 4: 2009, annex 1, clause 14.3.4).