Grace Medical ALTO Ossicular Prostheses - HSA Registration DE0503997
Access comprehensive regulatory information for Grace Medical ALTO Ossicular Prostheses in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503997 and owned by Grace Medical, Inc.. The device was registered on January 07, 2020.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Ossicular replacement prostheses surgically implanted into the middle ear as replacements for the malleus, incus, stapes, or a combination of the three function as a mechanical transformer and transmit sound energy from the tympanic membrane to the oval window of the cochlea. Indications: 1. Chronic middle ear disease 2. Otosclerosis 3. Congenital fixation of the stapes 4. Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery 5. Surgically correctable injury to the middle ear from trauma