FDA.reportPublic FDA data

RETEKESS

Primary DI
16945936705623
Brand
RETEKESS
Company
Xiamen New Sound Technology Co., Ltd.
Model
TE103
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
06945936705626PrimaryGS10
16945936705623Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945936705626069459367056266945936705626
1694593670562316945936705623

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, in-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 miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528181200
Device count
2
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945936701420NanoNano Sigma Beige2020-02-26
06945936701567OtofonixOtofonix Sona Beige2020-09-03
06945936703462VivtoneXpure2022-09-15
06945936703479VivtoneSmart2022-09-15
06945936703493NewSoundPrimo RA8012022-09-15
06945936703721NewsoundTactEar 8012023-11-17
06945936704063NanoFirst Ear Plus ITE2024-05-21
06945936704070NanoFirst Ear Plus BTE2024-05-21
06945936704087NanoFirst Ear Pro BTE2024-05-21
06945936703776NewsoundPrimo S2012024-01-19
06945936703714NewsoundPrimo SA4012023-11-17
06945936703394MDMDHearingAid VOLT2022-09-09
06945936703400NeosonicNeosonic MX-Smart2022-09-09
06945936703448NeosonicNeosonic BT-Omni2022-09-09
06945936703349NewSoundPoco XA6012022-09-08
06945936703363WENKEYWE-6012022-09-08
06945936703288NewsoundPOCO ZA4012022-09-05
06945936799106NewsoundHearIQ ITC2021-07-31
06945936799038OtofonixHelix2021-04-01
06945936799045OtofonixGroove2021-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296394029BeltoneGn Hearing A/SOSM2026-10-05
05708296394036BeltoneGn Hearing A/SOSM2026-10-05
05708296394098BeltoneGn Hearing A/SOSM2026-10-05
05708296394104BeltoneGn Hearing A/SOSM2026-10-05
05708296394111BeltoneGn Hearing A/SOSM2026-10-05
05708296394128BeltoneGn Hearing A/SOSM2026-10-05
05708296394135BeltoneGn Hearing A/SOSM2026-10-05
05708296394197BeltoneGn Hearing A/SOSM2026-10-05
05708296394203BeltoneGn Hearing A/SOSM2026-10-05
05708296394210BeltoneGn Hearing A/SOSM2026-10-05
05708296394487BeltoneGn Hearing A/SOSM2026-10-05
05708296394494BeltoneGn Hearing A/SOSM2026-10-05
05708296394555BeltoneGn Hearing A/SOSM2026-10-05
05708296394562BeltoneGn Hearing A/SOSM2026-10-05
05708296394579BeltoneGn Hearing A/SOSM2026-10-05
05708296394586BeltoneGn Hearing A/SOSM2026-10-05
05708296394593BeltoneGn Hearing A/SOSM2026-10-05
05708296394654BeltoneGn Hearing A/SOSM2026-10-05
05708296394661BeltoneGn Hearing A/SOSM2026-10-05
05708296394678BeltoneGn Hearing A/SOSM2026-10-05
05708296397877BeltoneGn Hearing A/SOSM2026-10-05
05708296397884BeltoneGn Hearing A/SOSM2026-10-05
05708296397945BeltoneGn Hearing A/SOSM2026-10-05
05708296397952BeltoneGn Hearing A/SOSM2026-10-05
05708296397969BeltoneGn Hearing A/SOSM2026-10-05
05708296429455BeltoneGn Hearing A/SOSM2026-10-05
05708296429462BeltoneGn Hearing A/SOSM2026-10-05
05708296429523BeltoneGn Hearing A/SOSM2026-10-05
05708296429530BeltoneGn Hearing A/SOSM2026-10-05
05708296429547BeltoneGn Hearing A/SOSM2026-10-05