안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.
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.
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Medical devices and their packaging do not bear the ce conformity marking, which does not comply with the requirements of articles 38 and 39 of the regulation; neither medical devices nor their packaging contain data on the manufacturer's authorized representative in the european economic area, which does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation; the batch / serial number is not specified, which does not meet the requirements of annex 1, paragraph 14.3.4 of the regulation; neither medical devices nor their packaging indicate any special medical device maintenance, use conditions, and warnings and / or precautions, which do not comply with annex 1, paragraph 14.3.9 of the regulation. - 14.3.11. requirements of sub-paragraphs.