Grace Medical Grace Pistons Stapes Prostheses - HSA Registration DE0509882
Access comprehensive regulatory information for Grace Medical Grace Pistons Stapes 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 DE0509882 and owned by Grace Medical, Inc.. The device was registered on October 08, 2024.
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.
Stapes replacement prostheses are surgically implanted into the middle ear as replacements for an immobile stapes due to otosclerosis. Piston or Bucket Handle prostheses function as a mechanical trans-former and transmit sound energy from the incus 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