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
Conformity marking ce and notified body no. 0297 and 1252 are used illegally.
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
There is no data on the manufacturer on the inner pack of the mp (does not meet the requirements of mn 4: 2009 annex 1, clause 14.3.1). the number of the notified body is not indicated on the labels of medical devices (does not meet the requirements of mn 4: 2009 40).
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
Do not affix the ce marking; no data on the manufacturer and the manufacturer's authorized representative in the european economic area; there is no information on safe and proper use of medical devices; 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
Labels are made by dentech corporation (japan). checking the information in the european database of medical devices eudamed revealed that this manufacturer's registration was terminated in 2009. (does not correspond to point 43 of the regulation); the label states that the authorized representative of the japanese manufacturer dentech corporation is the uk company four d rubber co. limited. four d rubber co., eudamed, the european database for medical devices. linited is registered as an authorized representative, but its list of manufacturers does not include the japanese manufacturer dentech corporation (does not meet point 45 of the regulation); conditions for the storage and / or maintenance of a non-specified medical device (for example, no indication of the means to be used for cleaning, disinfecting the medical device) (not in accordance with annex 1, point 14.3.9 of the regulation); the batch number on the drum punch label does not match the batch number on the medical device. medical devices do not bear the ce conformity marking (not in compliance with points 38 and 39 of the regulation); no data on the manufacturer and the manufacturer's authorized representative in the european economic area (not in compliance with annex 1, paragraph 14.3.1 of the regulation); batch / serial number not specified (not in compliance with annex 1, point 14.3.4 of the regulation); conditions for the storage and / or care of a non-specified medical device (for example, no indication of the means to be used for cleaning, disinfecting the medical device) (not in accordance with annex 1, point 14.3.9 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 conformity marking (not in compliance with the requirement of article 38 of the regulation); the label of the medical device does not contain information on the manufacturer and 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 of the medical device not specified (does not meet the requirement 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
Neither medical devices nor the outer packaging bear the ce marking and the number of the notified body; no data on 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 outer packaging and the instructions for use of the medical device do not mark the ce conformity marking and the number of the notified body, the medical device itself is not marked with 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
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
Medical devices do not bear the ce conformity marking (not in accordance with mn 4: 2009 item 38). no batch / serial number anywhere (does not meet mn 4: 2009, annex 1, clause 14.3.4), no medical device identifier information available on medical device itself (not in accordance with mn 4: 2009 annex 1, clause 14.3.2). 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 do not bear the ce conformity marking (not in accordance with mn 4: 2009 item 38). batch / serial number not specified anywhere (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.4), no medical device identifier information is available on the medical device itself (not in accordance with mn 4: 2009 annex 1, clause 14.3.2), not specified by manufacturer (does not conform to mn 4) : 2009 annex 1, clause 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
Batch / serial number not specified anywhere (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.4), no medical device identifier information is available on the medical device itself (not in accordance with mn 4: 2009 annex 1, clause 14.3.2), not specified by manufacturer (does not conform to mn 4) : 2009 annex 1, clause 14.3.1). 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
Batch / serial number not specified anywhere (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.4), no medical device identifier information is available on the medical device itself (not in accordance with mn 4: 2009 annex 1, clause 14.3.2), not specified by manufacturer (does not conform to mn 4) : 2009 annex 1, clause 14.3.1). 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 do not bear the ce conformity marking (not in accordance with mn 4: 2009 item 38). batch / serial number not specified anywhere (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.4), no medical device identifier information is available on the medical device itself (not in accordance with mn 4: 2009 annex 1, clause 14.3.2), not specified by manufacturer (does not conform to mn 4) : 2009 annex 1, clause 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 do not bear the ce conformity marking (not in accordance with mn 4: 2009 item 38). batch / serial number not specified anywhere (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.4), no medical device identifier information is available on the medical device itself (not in accordance with mn 4: 2009 annex 1, clause 14.3.2), not specified by manufacturer (does not conform to mn 4) : 2009 annex 1, clause 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
Packages of medical devices do not bear the ce conformity marking. 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 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 ce marking is not affixed to the medical device (does not meet the requirements of mn 4: 2009 38). batch / serial number not specified anywhere (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.4), no medical device identifier information is available on the medical device itself (not in accordance with mn 4: 2009 annex 1, clause 14.3.2), not specified by manufacturer (does not conform to mn 4) : 2009 annex 1, clause 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 do not bear the ce conformity marking (not in accordance with mn 4: 2009 item 38). batch / serial number not specified anywhere (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.4), no medical device identifier information is available on the medical device itself (not in accordance with mn 4: 2009 annex 1, clause 14.3.2), not specified by manufacturer (does not conform to mn 4) : 2009 annex 1, clause 14.3.1). 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 do not bear the ce conformity marking (not in accordance with mn 4: 2009 item 38). batch / serial number not specified anywhere (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.4), no medical device identifier information is available on the medical device itself (not in accordance with mn 4: 2009 annex 1, clause 14.3.2), not specified by manufacturer (does not conform to mn 4) : 2009 annex 1, clause 14.3.1). 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
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
Tooth-sealing materials filtek z250 does not bear the ce conformity marking and the notified body no. (does not meet the requirements of mn 4: 2009 38, 39 and 40). there is no notified body number on the outer packaging (does not meet the requirements of mn 4: 2009 40). there is no data available for an authorized representative in the european economic area (does not meet the requirements of mn 4: 2009 annex 1 clause 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
Endodontic needles (dental root canal needles) k-file densply bears the ce conformity marking, but no notified body number is given (does not meet the requirements of mn 4: 2009 item 40).
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 mp nor the packaging of the medical device bears the ce marking of conformity and the notified body no. (does not meet the requirements of mn 4: 2009 38, 39, 40). no manufacturer address and manufacturer's authorized representative in the european economic area (not in compliance with mn 4: 2009, annex 1, clause 14.3.1). no information is available on the safe and proper use of the medical device (not in accordance with mn 4: 2009 annex 1, clause 14.1).
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
The ce marking is not affixed to the medical device itself and the number of the notified body is not indicated (does not meet the requirements of mn 4: 2009 38, 39 and 40). the label of the medical device does not contain data on the manufacturer, his authorized representative in the european economic area (does not meet the requirements of mn 4: 2009 annex 1, clause 14.3.1), batch / serial number (does not meet the requirements of mn 4: 2009 annex 1, clause 14.3.4).