FDA.report

TOMORE

Primary DI
06976110831152
Brand
TOMORE
Company
Tomore Medical (Shenzhen) Co., Ltd
Model
7116(TE)
Device description
Hearing Aid
Published
2025-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications

CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06976110831152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06976110831152069761108311526976110831152

GMDN Terms

TermDefinition
Air-conduction hearing aid acoustic tubeA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
699487204
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06976110832319TOMORESuperMini-b2025-08-21
06976110832326TOMORESuperMini-br2025-08-21
06976110832333TOMOREAT2162025-08-21
06976110832340TOMOREEclarity mini2025-08-21
06976110832357TOMORE6116A2025-08-21
06976110832364TOMORE61182025-08-21
06976110832371TOMORE7116T2025-08-21
06976110832388TOMORE71162025-08-21
06976110832395TOMORE1216TE2025-08-21
06976110832401TOMORE5001H2025-08-21
06976110832418TOMORE5001L2025-08-21
06976110832425TOMORE508OE2025-08-21
06976110832432TOMORE5116A2025-08-21
06976110832449TOMORE5116B2025-08-21
06976110832456TOMORE5216A2025-08-21
06976110832463TOMORE5216B2025-08-21
06976110832470TOMORE5216C2025-08-21
06976110832487TOMORE5116AE2025-08-21
06976110832494TOMORE5216AE2025-08-21
06976110832500TOMOREEclarity LTE2025-08-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05714880292077WidexWidex A/SOSM2026-05-22
05714880292084WidexWidex A/SOSM2026-05-22
05714880292091WidexWidex A/SOSM2026-05-22
05714880292107WidexWidex A/SOSM2026-05-22
05714880292114WidexWidex A/SOSM2026-05-22
05714880292121WidexWidex A/SOSM2026-05-22
05714880292138WidexWidex A/SOSM2026-05-22
05714880292145WidexWidex A/SOSM2026-05-22
05714880292152WidexWidex A/SOSM2026-05-22
05714880292169WidexWidex A/SOSM2026-05-22
05714880292176WidexWidex A/SOSM2026-05-22
05714880292183WidexWidex A/SOSM2026-05-22
05714880292190WidexWidex A/SOSM2026-05-22
05714880292206WidexWidex A/SOSM2026-05-22
05714880292213WidexWidex A/SOSM2026-05-22
05714880292220WidexWidex A/SOSM2026-05-22
05714880292237WidexWidex A/SOSM2026-05-22
05714880292244WidexWidex A/SOSM2026-05-22
05714880292251WidexWidex A/SOSM2026-05-22
05714880292268WidexWidex A/SOSM2026-05-22
05714880292275WidexWidex A/SOSM2026-05-22
05714880292282WidexWidex A/SOSM2026-05-22
05714880292299WidexWidex A/SOSM2026-05-22
05714880292305WidexWidex A/SOSM2026-05-22
05714880292312WidexWidex A/SOSM2026-05-22
05714880292329WidexWidex A/SOSM2026-05-22
05714880292336WidexWidex A/SOSM2026-05-22
05714880292343WidexWidex A/SOSM2026-05-22
05714880292350WidexWidex A/SOSM2026-05-22
05714880292367WidexWidex A/SOSM2026-05-22