TOMORE

Basic Information

• Brand Name: TOMORE
• Primary DI: 06977275990401
• Version / Model: 5216A
• Company Name: Tomore Healthcare (Dongguan) Co.,Ltd.
• Labeler DUNS: 844874890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-25
• Public Version: 1
• Public Version Date: 2024-12-03
• Public Version Status: New
• Public Device Record Key: 0511250a-618f-446b-b72e-835cd85ed1eb

Device Description

Hearing Aid

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	874.3300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62260	Air-conduction hearing aid acoustic tube	A small tubular detachable device designed to conduct sound waves from an air-conduction hearing aid [e.g., behind-the-ear (BTE)] to an earmould to convey acoustic output to the eardrum. It is made of soft synthetic polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06977275990401	GS1