ANVISA registration

Sistema Trans Obturador Ajustável Masculino (ATOMS)

Registration 80984190095. Implante esfincter

Registration details

Registration number80984190095
Application number25351093479202527
Technical nameImplante esfincter
Risk classIII
Published on31/08/2026
ValidityValid until 31/08/2036

Registration holder

Legal nameGADALI MEDICAL COMÉRCIO DE PRODUTOS MÉDICO-HOSPITALAR LTDA. ME
CNPJ06.143.957/0001-73

Manufacturer

  • A.M.I AGENCY FOR MEDICAL INNOVATIONS GMBH ÁUSTRIA

Other registrations held by GADALI MEDICAL COMÉRCIO DE PRODUTOS MÉDICO-HOSPITALAR LTDA. MEview all

Sonda Basket

80984190001

CATETER PARA HISTEROSSALPINGOGRAFIA E HISTEROSSONOGRAFIA

80984190002

Fio-Guia Hidrofílico

80984190003

Conjunto Dilatador Renal Graduado Tipo Amplatz e Acessórios

80984190004

Fio-Guia Zebrado

80984190005

Fio-Guia Teflonado

80984190006

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