all products manufactured by the company that manufactures medical-dental equipment, MZ INDÚSTRIA E COMÉRCIO LTDA 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 MZ INDÚSTRIA E COMÉRCIO LTDA 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

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.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    751
  • 날짜
    2003-10-30
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    considering paragraph 3 of art. 111 of the Internal Regulation approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering the arts. 12 and 25 of Law no. 6,360, September 23, 1976; considering items XXIX, XXXV of art. 10, of Law no. No. 6,437, August 20, 1977; considering items IX, X, XV, XXIV, all of art. 7 of Law No. 9,782, of January 26, 1999; considering CVS communiqué 350/2003 GT Correlatos DITEP, published in the Official Gazette of the State of São Paulo on October 16, 2003, regarding the Notice of Infringement No. 01015 ¿AIP 01059 and TIP 02464, drawn up by the Municipal Health Department of Ribeirão Black, on the 25th day of February 2003
  • 원인
    Do not have registration with anvisa, imposing health risk.
  • 조치
    Determine, as a measure of sanitary interest, throughout Brazil, the suspension of the manufacture and sale of all products manufactured by the company that manufactures medical-dental equipment, MZ INDÚSTRIA E COMÉRCIO LTDA, at Rua Santos nº 1121, Vila Elisa , Ribeirão Preto / SP, for not having registered with ANVISA, imposing health risk.

Manufacturer

  • Source
    ANVSANVISA