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 (not in compliance with point 14.3.1 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
Examination of the information in the european database of medical devices eudamed has shown that the same purpose medical devices of other manufacturers are certified; the medical devices do not bear the ce marking and the number of the notified body (not in compliance with points 38, 39 and 40 of the regulation); there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area (not in compliance with point 14.3.1 of annex 1 to the regulation); there is no indication that the medical device is sterile (does not comply with point 14.3.3 of annex 1 to the regulation); the date (month and year) on which the medical device may be used safely on the label of the medical device (does not comply with point 14.3.5 of annex 1 to the regulation); there is no indication that medical devices are intended for single use (not in compliance with annex 1, paragraph 14.3.6 of the regulation); no special storage conditions for medical devices (not in compliance with annex 1, paragraph 14.3.9 of the regulation); warnings and / or precautionary measures not provided (not in accordance with annex 1, point 14.3.11 of the regulation); all information on the medical device packages is not in the european community language and the information provided is not identifiable (does not comply with article 4 (4) of council directive 93/42 / eec).
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); 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
Medical devices not bearing the ce conformity marking (not in accordance with point 38 of the regulation), no data on the manufacturer and his authorized representative in the european economic area (not in accordance with annex 1, point 14.3.1 of the regulation) not specified in batch / serial number (does not meet the requirement of annex 1, paragraph 14.3.4 of the regulation); date (year and month) up to which the medical device may be used safely (does not meet the requirement of annex 1, paragraph 14.3.5 of the regulation); that the medical device is intended for single use (does not meet the requirement of annex 1, paragraph 14.3.6 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
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
Medical devices do not bear the ce conformity marking and the identification number of the notified body (not in accordance with points 38 and 40 of the regulation), no data are available on the manufacturer and his authorized representative in the european economic area (not in compliance with the requirements of annex 1, points 14.3.1 and 14.6.1 of the regulation); batch / serial number not specified (does not meet the requirement of annex 1, paragraph 14.3.4 of the regulation), date (year and month) when the medical device may be used safely (not in compliance with the requirement of annex 1, paragraph 14.3.5 of the regulation), year of manufacture of active medical devices ( not comply with the requirements of annex 1, paragraph 14.3.12 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 ce marking is not affixed to medical devices; there is no data on the manufacturer and his authorized representative in the eea; batch / serial number not specified; unspecified date (month and year) until the medical device (device) can be used safely; indicated that the medical device is intended for single 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 ce marking is not affixed to medical devices; there is no data on the manufacturer and his authorized representative in the eea; batch / serial number not specified; unspecified date (month and year) until the medical device (device) can be used safely; indicated that the medical device is intended for single 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
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
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).
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
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 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
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
Name and address of manufacturer not specified (not in accordance with mn 4: 2009 annex 1 clause 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); 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); 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
Neither the label nor the packaging nor the instructions for use bear the ce conformity marking (does not comply with the requirements of mn 4: 2009 38 and 39); there is no data about the manufacturer and the manufacturer's authorized representative in the eea (does not meet the requirements of mn 4: 2009 clause 14.3.1); 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
The lenses themselves, their labels or the ce marking (not in conformity with mn 4: 2009, paragraphs 38 and 39); there is no data about the manufacturer and the manufacturer's authorized representative in the eea (does not meet the requirements of mn 4: 2009 clause 14.3.1); 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
Neither the frames themselves nor their labels, nor the packaging or instructions for use bear the ce conformity marking (does not comply with the requirements of mn 4: 2009 38 and 39); there is no data about the manufacturer and the manufacturer's authorized representative in the eea (does not meet the requirements of mn 4: 2009 clause 14.3.1); 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 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).
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 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).
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 (does not meet mn 4: 2009 annex 1 clause 14.3.4); the address of the manufacturer is not specified and there is no data on the authorized representative in the eea (does not meet the requirements of mn 4: 2009 annex 1 clause 14.3.1).