FDA.reportPublic FDA data

KYTO

Primary DI
06978096608803
Brand
KYTO
Company
KYTO FITNESS TECHNOLOGY CO., LIMITED
Model
KYTO2880
Published
2025-02-26
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
06978096608803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978096608803069780966088036978096608803

GMDN Terms#

Term, Definition table
TermDefinition
Glomerular basement membrane antibody (Goodpasture antibody) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antibodies to glomerular basement membrane (anti-GBM) or Goodpasture antibodies in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526968903
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978096608896KYTOKYTO28802025-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06980305290037CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290044CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290068CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290082CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290099CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290105CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290112CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290129CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980134820016n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820023n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820030n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09