Sistema Trans Obturador Ajustável Masculino (ATOMS)

Sphincter implant · class III · Until 31/08/2036

Registration no.
80984190095
Process no.
25351093479202527
Status
Until 31/08/2036
Device type
Sphincter implant (Implante esfincter)
Risk class
III
Registration holder
GADALI MEDICAL COMÉRCIO DE PRODUTOS MÉDICO-HOSPITALAR LTDA. ME CNPJ 06.143.957/0001-73 · 121 registrations
Manufacturer
A.M.I AGENCY FOR MEDICAL INNOVATIONS GMBH · Austria
Published
31/08/2026
Valid until
31/08/2036
Last updated by ANVISA
2026-10-12
Official record
View on ANVISA ↗

Other sphincter implant registrations (4 in total, see all)

ProductClass HolderPublishedStatus
AMS 800™ Esfíncter urinário artificial
10341351014
III BOSTON SCIENTIFIC DO BRASIL LTDA 06/03/2023 Until 06/03/2033
VICTO
10306840191
III PROMEDON DO BRASIL PRODUTOS MEDICO HOSPITALARES LTDA 20/09/2021 Until 20/09/2031
AMS 800™ Esfíncter urinário artificial com InhibiZone
10341351010
IV BOSTON SCIENTIFIC DO BRASIL LTDA 12/12/2022 Until 12/12/2032