FDA.reportPublic FDA data

TOMORE

Primary DI
06977275990807
Brand
TOMORE
Company
Tomore Healthcare (Dongguan) Co.,Ltd.
Model
APT818TE
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
06977275990807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977275990807069772759908076977275990807

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
06977275990814TOMORE51222024-11-26
06977275990821TOMORE51242024-11-26
06977275990838TOMORE51202024-11-26
06977275990845TOMORE51262024-11-26
06977275990852TOMORE51282024-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973967150658EaraXiamen Vienatone Medical Technology Co., Ltd.QUG2026-05-19
06971094538677AntOkayHuizhou Jinghao Medical Technology Co., LtdQUG2026-05-01
06973967150351Audien HearingXiamen Vienatone Medical Technology Co., Ltd.QUG2026-04-28
00860015094803LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094810LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094827LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094834LegatoLEGATO AUDIO, INC.QUG2026-03-25
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
05714880290325hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290332hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290349hear.comWs Audiology Usa, Inc.QUG2026-01-12
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
06975958551277MirasingXiamen Mirasing Technology Co.,Ltd.QUG2025-11-03
00810153660828Lexie H1 OTC Hearing BudsHEARX GROUP (PTY) LTDQUG2025-10-01
06971094538486H-earrings Huizhou Jinghao Medical Technology Co., LtdQUG2025-10-01
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