FDA.reportPublic FDA data

TOMORE

Primary DI
06977275990487
Brand
TOMORE
Company
Tomore Healthcare (Dongguan) Co.,Ltd.
Model
AT216
Device description
Hearing Aid
Published
2024-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QUFHearing Aid, Air-Conduction, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUFHearing Aid, Air-Conduction, Over The CounterEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977275990487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977275990487069772759904876977275990487

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
06943786093726AUDIENAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUF2026-09-20
06943786094792AUDIENAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUF2026-09-20
06971094538844N/AHuizhou Jinghao Medical Technology Co., LtdQUF2026-08-23
06971094538806Modern HearingHuizhou Jinghao Medical Technology Co., LtdQUF2026-08-01
06971094538790SOUNDFITHuizhou Jinghao Medical Technology Co., LtdQUF2026-07-03
00850065321714CeretoneAudicon CorporationQUF2026-06-25
00850065321752CeretoneAudicon CorporationQUF2026-06-25
06971094538783Smart HearingHuizhou Jinghao Medical Technology Co., LtdQUF2026-06-22
06977171530046TECHMITechmi (HongKong) Co., LimitedQUF2026-06-10
06977171530008TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06977171530015TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06977171530022TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06977171530039TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06971094538721KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538738KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538707XQYMHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-08
06971094538691OricleHuizhou Jinghao Medical Technology Co., LtdQUF2026-04-30
06973967150276WuveeXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150283NebrooXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150313VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150320VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150368NebrooXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150573VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06971094538622Savvy SmartHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-25
06971094538639Spade & CoHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-24
06971094538615GIATATHAHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-20
06971094538592LITOULFHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-18
06950715563090CofoeCofoe Medical Technology Co.,LtdQUF2026-02-24
06971094538585Bachgold Huizhou Jinghao Medical Technology Co., LtdQUF2026-02-05
06979053570034UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21