Alerta De Seguridad para HEMODIALYSIS MACHINE, MODEL DBB-26

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.

Considering the provisions of 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 item X, of Article 10, of Law No. 6.437, of August 20, 1977; considering Arts. 6, 12 and 25-§ 2 of Law 6360 of September 23, 1976 c / c Arts. 7, 14 and 35 of Decree No. 79094 of January 5, 1977; considering paragraph 2 (a) of Part 5 of Resolution RDC-185, dated October 22, 2001 c / c Art. 9 of Resolution RE-444, dated August 31, 1999, with CERTUSP / USP / IEE / Document No. 2004EC01CE004, dated 05/01/2004, informing the cancellation of the product certification process; considering Arts. 7, III, XIV, XV, XXIV and Art. 8, VI of Law 9782, of January 26, 1999