Pure Global
Singapore HSA registration DE0509882

Grace Medical Grace Pistons Stapes Prostheses

Singapore flagSingapore·CLASS C·Grace Medical, Inc.·Registered October 08, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0509882
Registration Date
October 08, 2024
Retention Due Date
October 07, 2025
Product description
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
Product Owner
Name
Grace Medical, Inc.
Short Name
Grace Medical, Inc.
Address
8500 Wolf Lake Drive, Suite 110, Memphis, Tennessee, 38133, UNITED STATES
Registrant
Name
EASMED ASIA PTE. LTD.
Address
11 LORONG 3 TOA PAYOH, BLOCK B JACKSON SQUARE, #01-13, SINGAPORE 319579
Importer
Name
EASMED ASIA PTE LTD EASMED PTE LTD
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)
GRACE PISTON 0.4MM DIA X 3.75MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.4MM DIA X 4.00MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.4MM DIA X 4.25MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.4MM DIA X 4.50MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.4MM DIA X 4.75MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.4MM DIA X 5.00MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.4MM DIA X 6.00MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.5MM DIA X 3.75MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.5MM DIA X 4.00MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.5MM DIA X 4.25MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.5MM DIA X 4.50MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.5MM DIA X 4.75MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.5MM DIA X 5.00MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.5MM DIA X 5.50MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.5MM DIA X 6.00MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.6MM DIA X 3.75MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.6MM DIA X 4.00MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.6MM DIA X 4.25MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.6MM DIA X 4.50MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.6MM DIA X 4.75MM L PLATINUM RIBBON/FLUOROPLASTIC GRACE PISTON 0.6MM DIA X 5.00MM L PLATINUM RIBBON/FLUOROPLASTIC
Model Identifier(s)
412-375 412-400 412-425 412-450 412-475 412-500 412-600 452-375 452-400 452-425 452-450 452-475 452-500 452-550 452-600 453-375 453-400 453-425 453-450 453-475 453-500
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C