FDA.reportPublic FDA data

TOMORE

Primary DI
06977275990975
Brand
TOMORE
Company
Tomore Healthcare (Dongguan) Co.,Ltd.
Model
5118L
Device description
Hearing Aid
Published
2024-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06977275990975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977275990975069772759909756977275990975

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
844874890
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977275990654TOMORENecklace Hearing Aids2024-11-26
06977275990661TOMOREIn-THE-EAR-Hearing Aids(Faceplate Kits Included)2024-11-26
06977275990678TOMOREOTC, Behind-THE-EAR Hearing Aids2024-11-26
06977275990685TOMOREOne-FIT-ALL-In-THE-E AR Hearing Aids(Faceplate Kit2024-11-26
06977275990692TOMOREAnalog Hearing Aids2024-11-26
06977275990708TOMOREBTE2024-11-26
06977275990715TOMORECIC2024-11-26
06977275990722TOMORERIC2024-11-26
06977275990739TOMOREITE2024-11-26
06977275990746TOMOREOpen Fit2024-11-26
06977275990753TOMORE5120L2024-11-26
06977275990760TOMORE52162024-11-26
06977275990777TOMOREAPT516TE-RIC2024-11-26
06977275990784TOMOREAPT616TE-RIC2024-11-26
06977275990791TOMOREADR-816TE2024-11-26
06977275990807TOMOREAPT818TE2024-11-26
06977275990814TOMORE51222024-11-26
06977275990821TOMORE51242024-11-26
06977275990838TOMORE51202024-11-26
06977275990845TOMORE51262024-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979809410003Hearing AidsShenzhen Anker Medical Devices Co., Ltd.QUG2026-09-22
06943786094839AUDIENAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2026-09-20
06977352080612ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080629ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080681ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080698ELEHEARELEHEAR Inc.QUG2026-09-05
06974608620523PHONELUMShenzhen Eartech Co., Ltd.QUG2026-08-27
00850080488577flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-08-25
00850080488584flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-08-25
00850065321967CeretoneAudicon CorporationQUG2026-08-14
06943786094846AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2026-08-14
08056262819890nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
08056262856789nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
06980305290013CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290020CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290037CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290044CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290068CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290082CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290099CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290105CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290112CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290129CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980134820016n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820023n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820030n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820047n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820054n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820061n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820078n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09