FDA.reportPublic FDA data

TUITUI

Primary DI
06974608620097
Brand
TUITUI
Company
Shenzhen Eartech Co., Ltd.
Model
Sara 3
Device description
In-the-ear hearing aid, model Sara 3 (SE). The device consists of a housing, microphone, signal processor, receiver, ear tips and battery. Following assessment and fitting, it is intended for people with air-conduction hearing loss.
Published
2026-11-02
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

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
06974608620097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974608620097069746086200976974608620097

Regulatory Flags#

DUNS number
419851619
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
false
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
06974608620042TUITUISara 102026-11-02
06974608620066TUITUISara 42026-11-02
06974608620073TUITUIZTQ03ZT2026-11-02
06974608620103TUITUISara 52026-11-02
06974608620158TUITUISara 82026-11-02
06974608620202TUITUIZTQ05ZT2026-11-02
06974608620219TUITUIZTQ04ZT Pro2026-11-02
06974608620240TUITUISara 12026-11-02
06974608620523PHONELUMSara 102026-08-27
06974608620059TUITUI HearingZTQ01ZT2025-04-30
06974608620004TUITUIZTQ01ZT Pro2025-02-12
06974608620011TUITUIZTQ02ZT 2025-02-12
06974608620028TUITUIZTQ02ZT Pro2025-02-12
06974608623067TUITUIZTQ01ZT2025-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971094539506JinghaoHuizhou Jinghao Medical Technology Co., LtdQUG2026-11-05
06974608620042TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620066TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620073TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620103TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620158TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620202TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620219TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
06974608620240TUITUIShenzhen Eartech Co., Ltd.QUG2026-11-02
00777799619927nuance audioLUXOTTICA GROUP SPAQUG2026-10-27
08056262930700nuance audioLUXOTTICA GROUP SPAQUG2026-10-27
06977171530190TECHMITechmi (HongKong) Co., LimitedQUG2026-09-30
06977171530206TECHMITechmi (HongKong) Co., LimitedQUG2026-09-30
06977171530220TECHMITechmi (HongKong) Co., LimitedQUG2026-09-30
06977189201167NAYeasound (Xiamen) Hearing Technology Co., LtdQUG2026-09-30
06979809410003Hearing AidsShenzhen Anker Medical Devices Co., Ltd.QUG2026-09-22
06943786094839AUDIENAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2026-09-20
06977352080612ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080629ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080681ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080698ELEHEARELEHEAR Inc.QUG2026-09-05
06974608620523PHONELUMShenzhen Eartech Co., Ltd.QUG2026-08-27
00850080488577flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-08-25
00850080488584flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-08-25
00850065321967CeretoneAudicon CorporationQUG2026-08-14
06943786094846AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2026-08-14
08056262819890nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
08056262856789nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
06980305290013CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290020CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25