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 of the medical device, 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 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
The medical equipment contained in the batch is packed individually in one piece of paper in a single box with a total of 5 boxes. all boxes are placed in a paper transport envelope; all boxes and discs do not include the manufacturer's name, address and manufacturer's authorized representative in the european economic area (not in compliance with the requirement of annex 1, paragraph 14.3.1 of the regulation); all boxes and discs do not bear the ce conformity marking and the notified body number (not in accordance with the requirements of articles 38, 39 and 40 of the regulation); the three packages do not contain information identifying the contents of the package (does not meet the requirements of article 14.3.2 of the regulation); no batch / serial number on the two packages marked peek dental disc (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 orthopedic screws in the bundle are packed in plastic bags with a label affixed to them. no additional information on these propellers or their use has been added to the packaging. the label shows the manufacturer of the medical device: vigor ortho (india) but does not specify the manufacturer's authorized representative in the european community (does not meet the requirement of annex 1, paragraph 14.3.1 of the regulation); the label states that the medical device is placed on the market non-sterile but does not provide information on how this medical device should be sterilized before its intended use (implantation) (does not meet the requirement of annex 1, paragraph 14.3.10 of the regulation); eudamed, the european database for medical devices, has no information on the manufacturer vigor ortho (india), and there is no information that this manufacturer will be issued with a certificate of compliance with the requirements of the council directive 93/42 / eec on medical devices. commodities are ce marked with the number of the notified body 2107. the list of notified bodies of existing medical devices published by the european commission in the notified bodies of the european commission does not include the notified body number 2107 (does not meet 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 (does not meet the requirements of points 38 and 39 of the regulation); the label on the medical device does not contain information on the manufacturer and the manufacturer's authorized representative in the european economic area (not in compliance with 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
According to the photos presented, 500 pcs. spirometric mouthpieces are packed in a single plastic bag without any inscriptions and into the transport box. individual spirometer tips are not packaged in separate packages with mandatory information and therefore do not comply with point 38 of the regulation and points 9.6, 14.1 and 14.3 of annex i.
Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lithuania.
Notas adicionales en la data
Causa
Packages (labels) of medical devices are marked with the symbol "see instructions for use", but the instructions for use are not included (not in accordance with the requirements of annex 1, paragraph 14.1 of the regulation); medical device labels do not specify any special medical device care conditions, warnings, and / or precautions (and do not meet the requirements of 14.1.9 - 14.3.11 of annex 1 to the regulation).
Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lithuania.
Notas adicionales en la data
Causa
Medical devices are not affixed with 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); manufacturer name and address not specified (not in accordance with annex 1, paragraph 14.3.1 of the regulation); batch / serial number not specified (not in accordance with annex 1, paragraph 14.3.4 of the regulation); unspecified date by which the medical device may be used safely (not in compliance with the requirements of article 14.3.5 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); the packaging of the medical device is indicated by an authorized representative of emergo europe bv (the netherlands), and the authorized representative of the manufacturer in the customs documentation is designated by unimedica ltd (bulgaria). a manufacturer who places medical devices on the market in his own name and has no registered office in the european economic area must appoint one authorized representative in the european economic area (not in compliance with the requirements of article 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
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
Medical devices are not affixed with 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); medical devices do not have an authorized representative of the data manufacturer in the european economic area (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 are not affixed with 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); 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); medical device labels do not contain the information necessary to identify the medical device and the contents of the package (not in compliance with the requirements of annex 1, paragraph 14.3.2 of the regulation); no batch / serial number of the medical device (does not meet the requirement of annex 1, paragraph 14.3.4 of the regulation); conditions for the storage and maintenance of the special medical device, special conditions of use and warnings and precautions (not in compliance with the requirements of 14.3.9, 14.3.10, 14.3.11 of annex 1 to the regulation) are not specified.
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 are not affixed with 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); 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).
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 is not marked with the number of the notified body (does not comply with points 39 and 40 of the regulation); no information on the manufacturer and its address is provided on the label of the medical device or in the instructions for use (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); the name of the model (hdcure max) on the label embedded in the medical device packaging does not match the model name on the label of the medical device (does not meet the requirement of annex 1, paragraph 14.3.2 of the regulation).
Acción
Cancel and remove from the market of the Republic of Lithuania
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
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
Manufacturer and its authorized representative in the european economic area not indicated on the label of the medical device and on the outer packaging and the address is not specified (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); packages of medical devices are not marked with 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); the medical device label is marked with the symbol "see instructions for use", but the instructions for use are not included (does not meet the requirements of annex 1, paragraph 14.1 of the regulation); medical device labels do not contain the information necessary to identify the medical device and the contents of the packaging (not in compliance with the requirements of annex 1, paragraph 14.3.2 of the regulation); the expiry date of the medical device labels is "2017-0919". in view of this, the period of validity (fitness for use) of medical devices has expired and can no longer be used.
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 devices are marked with two ce conformity marks with the number of the notified bodies 1282 and 0197. in accordance with the provisions of the regulation, the ce marking must be accompanied by the identification number of one of the notified bodies responsible for applying the procedures set out in the annexes to this regulation. in addition, the ce mark does not conform to the form set out in annex 12 to the regulation. such marking does not comply with the requirements of articles 38-40 of the regulation; instructions for use have not been added to medical devices as required by annex 1, paragraph 14.1 of the regulation; medical devices do not include the name and address of the manufacturer and the authorized representative within the european union and its address as required by 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 as required by articles 38-40 of the regulation; no instructions for use added to the medical device as required by annex 1, paragraph 14.1 of the regulation; the name and address of the manufacturer and the authorized representative in the european union and its address, as required by point 14.3.1 of annex 1 to the regulation; no specific medical device maintenance, use conditions and warnings and / or precautionary measures, as required by 14.3.9-14.3.12 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
The device does not bear the ce conformity marking as required by articles 38-40 of the regulation; no instruction manual attached to the device as required by annex 1, paragraph 14.1 of the regulation; the device does not include the name and address of the manufacturer and the authorized representative in the european union and its address as required by annex 1, paragraph 14.3.1 of the regulation; no batch / serial number of the device as required by 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
On the label of the medical device, on the outer packaging, the instructions for use do not contain information on the manufacturer's authorized representative in the european economic area and the address of the manufacturer is not specified (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); the instrument and its packaging do not mark the ce conformity marking (does not comply with the requirements of article 38 of the regulation), the intended use of the product is not specified in the package leaflet, contraindications (does not comply with the requirements of annex 1, paragraph 14.6 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
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); 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); unspecified batch / serial number 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
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
Only the outer packaging of medical devices bears the ce conformity marking, but the ce marking is not affixed to the medical device itself (does not meet 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); the batch / serial number of the medical device is 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
Medical devices and labels do not bear the ce conformity marking and the number of the notified body (not in compliance with points 38, 39 and 40 of the regulation); there are no instructions for use attached to medical devices (not in compliance with clause 14.1 of annex 1 to the regulation); the medical device labels do not contain information on the manufacturer's authorized representative in the european economic area (not in compliance with annex 1, paragraph 14.3.1 of the regulation); method of sterilization of medical devices not indicated on the labels of medical devices (does not comply with point 14.3.10 of annex 1 to the regulation); the batch number of 135 ° on the hip plate with 3 holes (not in accordance with annex 1, paragraph 14.5 of the regulation); labeled by vigor ortho (india). after checking the information in the eudamed, such a manufacturer is not registered.