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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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.