LAMINAS DE BISTURI SOLIDOR - Packing with 100 units. - REGISTER NUMBER: 10237580002 의 안전성 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.

The Director of the Collegiate Board of the National Sanitary Surveillance Agency, in the use of the attribution conferred by Administrative Rule 327 of May 16, 2003, considering paragraph 3 of art. 111 of the Internal Regulations approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering Art. 7 of Law 6360, of September 23, 1976; considering item XV, of Article 10, of Law No. 6.437, of August 20, 1977; considering items XV of Article 7 of Law 9782, of January 26, 1999; considering the research report sent by TECNOVIGILÂNCIA / GGTPS through Order no. 14/2003, decides: Art. 1 To determine, as a measure of sanitary interest, throughout the national territory, the suspension of the manufacture and sale of the product BLADE OF BISTURI SOLIDOR , manufactured by the company LAMEDID COMERCIAL E SERVIÇOS LTDA, located at Avenida Aruana, 1200, Tamboré, Barueri / SP, because it is being commercialized without a current registration and presents a quality deviation, imposing a risk to public health. Article 2 The above mentioned company is hereby intimated in this act to present, wanting, its defense or impugnation, which will have the period of 15 (fifteen) days. Article 3 This Resolution shall enter into force on the date of its publication.