FDA.reportPublic FDA data

TOMORE

Primary DI
06976110831299
Brand
TOMORE
Company
Tomore Medical (Shenzhen) Co., Ltd
Model
3308A(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
Single use
true

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976110831299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976110831299069761108312996976110831299

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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

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Primary DI, Brand, Company table
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05714880219951Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
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