FDA.reportPublic FDA data

TOMORE

Primary DI
06976110831411
Brand
TOMORE
Company
Tomore Medical (Shenzhen) Co., Ltd
Model
5122(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

Product Codes#

Code, Name table
CodeName
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976110831411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976110831411069761108314116976110831411

GMDN Terms#

Term, Definition table
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 table
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080488249flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-03-06
16974308960209Retone, NebrooXiamen Retone Hearing Technology Co., LtdQUG2026-02-05
00850080488140flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-01-16
05714880290356hear.comWs Audiology Usa, Inc.QUG2026-01-12
16974308960193Retone Xiamen Retone Hearing Technology Co., LtdQUG2026-01-08
06977352080438ELEHEARELEHEAR Inc.QUG2025-12-31
06943786079911AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2025-12-03
05708296386239GN HearingGn Hearing A/SQUG2025-09-21
05708296386246GN HearingGn Hearing A/SQUG2025-09-21
05708296391240GN HearingGn Hearing A/SQUG2025-09-21
05708296386253GN HearingGn Hearing A/SQUG2025-09-19
05708296386260GN HearingGn Hearing A/SQUG2025-09-19
05708296386277GN HearingGn Hearing A/SQUG2025-09-19
05708296386284GN HearingGn Hearing A/SQUG2025-09-19
05708296386291GN HearingGn Hearing A/SQUG2025-09-19
05708296386307GN HearingGn Hearing A/SQUG2025-09-19
05708296386314GN HearingGn Hearing A/SQUG2025-09-19
05708296386321GN HearingGn Hearing A/SQUG2025-09-19
05708296386338GN HearingGn Hearing A/SQUG2025-09-19
05708296386345GN HearingGn Hearing A/SQUG2025-09-19
05708296386352GN HearingGn Hearing A/SQUG2025-09-19
05708296386369GN HearingGn Hearing A/SQUG2025-09-19
05708296386376GN HearingGn Hearing A/SQUG2025-09-19
05708296391189GN HearingGn Hearing A/SQUG2025-09-19
05708296391196GN HearingGn Hearing A/SQUG2025-09-19
05708296391202GN HearingGn Hearing A/SQUG2025-09-19
05708296391219GN HearingGn Hearing A/SQUG2025-09-19
05708296391226GN HearingGn Hearing A/SQUG2025-09-19
05708296391233GN HearingGn Hearing A/SQUG2025-09-19
05708296391257GN HearingGn Hearing A/SQUG2025-09-19