ANVISA registration

Cateter de Litotripsia Intravascular (IVL) Sonico-CX

Registration 10256400086. Cateter balão para sistema de litotripsia intravascular, coronário

Registration details

Registration number10256400086
Application number25351074316202545
Technical nameCateter balão para sistema de litotripsia intravascular, coronário
Risk classIV
Published on21/07/2025
ValidityValid until 21/07/2035

Registration holder

Legal nameBIOMEDICAL PRODUTOS CIENTIFICOS MEDICOS E HOSPITALARES S A
CNPJ19.848.316/0001-66

Manufacturer

  • SPECTRUMEDICS MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD CHINA, REPÚBLICA POPULAR

Other registrations held by BIOMEDICAL PRODUTOS CIENTIFICOS MEDICOS E HOSPITALARES S Aview all

CATETER PARA EMBOLECTOMIA LUCAS MEDICAL

10256400006

CATETER DIAGNOSTICO ANGIOGRAFICO RADIOLOGICO

10256400022

CATETER ELETRODO TEMPORARIO

10256400025

ENXERTO VASCULAR COM COLÁGENO V.U.P.

10256400036

Bainha Dilatadora TightRail

10256400040

Pulseira de Compressão BIRD

10256400041

Source: ANVISA

Source: ANVISA open data, medical device file, updated daily. The public database provides registration validity, rather than registration status: this registration may have been cancelled before its expiry date without this being shown here. Before making purchasing, import or marketing decisions, check the ANVISA search portal.

Next step

Medical device registration with ANVISA

HSC manages the process from risk classification to liaising with the regulator, in Brazil and more than 40 other countries.

Speak to a specialist