FDA.report

TIANLE

Primary DI
06937572804580
Brand
TIANLE
Company
Zhongshan Tianle Hearing Technology Co., Ltd.
Model
TE-006M
Device description
Behind The Ear Hearing Aid
Published
2025-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
QSMSystem, Surgical, Computer Controlled Instrument, Remanufactured

Product Code Classifications

CodeDeviceSpecialtyClass
QSMSystem, Surgical, Computer Controlled Instrument, RemanufacturedGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06937572804580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06937572804580069375728045806937572804580

GMDN Terms

TermDefinition
Air-conduction hearing aid, behind-the-earA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods

Method

Regulatory Flags

DUNS number
546790267
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DIBrandModelCatalogPublished
06937572802470TIANLETF-950F2025-04-02
06937572802487TIANLETF-951F2025-04-02
06937572803750TIANLETL-621G2025-04-02
06937572803767TIANLETL-622G2025-04-02
06937572803774TIANLETL-623G2025-04-02
06937572803781TIANLETL-625G2025-04-02
06937572803798TIANLETL-626G2025-04-02
06937572803804TIANLETL-628G2025-04-02
06937572803811TIANLETL-629G2025-04-02
06937572803828TIANLETL-630G2025-04-02
06937572803835TIANLETL-631G2025-04-02
06937572803842TIANLETL-632G2025-04-02
06937572803859TIANLETL-633G2025-04-02
06937572803866TIANLETL-635G2025-04-02
06937572803873TIANLETL-636G2025-04-02
06937572803880TIANLETL-638G2025-04-02
06937572803897TIANLETL-639G2025-04-02
06937572803903TIANLETL-650G2025-04-02
06937572803910TIANLETL-651G2025-04-02
06937572803927TIANLETL-652G2025-04-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06937572804399TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804405TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804412TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804429TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804436TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804443TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804450TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804467TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804474TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804481TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804498TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804504TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804511TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804528TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804535TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804542TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804559TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804566TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804573TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804597TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804603TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804610TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804627TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804634TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804641TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804658TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804665TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804672TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804689TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02
06937572804696TIANLEZhongshan Tianle Hearing Technology Co., Ltd.QSM2025-04-02