Singapore HSA registration DE0503996
Grace Medical Wedge Incus Struts Ossicular Prostheses
Singapore·CLASS C·Grace Medical, Inc.·Registered January 07, 2020Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0503996
- Registration Date
- January 07, 2020
- Change Notification Approval Date
- November 01, 2021
- Retention Due Date
- January 06, 2026
Product description
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
Product Owner
- Short Name
- Grace Medical, Inc.
- Address
- 8500 Wolf Lake Drive, Suite 110, Memphis, Tennessee, 38133, UNITED STATES
Registrant
- Address
- 11 LORONG 3 TOA PAYOH, BLOCK B JACKSON SQUARE, #01-13, SINGAPORE 319579
Importer
- Address
- 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579
Model information
- Model Name(s)
- WEDGE INCUS STRUT LONG SIZERS INCLUDED TITANIUM/SILICONE WEDGE INCUS STRUT SHORT SIZERS INCLUDED TITANIUM/SILICONE MOLDED OTOLOGIC SIZERS Polypropylene TRIAL ONLY - DO NOT IMPLANT MOLDED OTOLOGIC SIZERS Polypropylene TRIAL ONLY - DO NOT IMPLANT
- Model Identifier(s)
- 656 657 965 966
About this record
Access comprehensive regulatory information for Grace Medical Wedge Incus Struts 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 DE0503996 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C