FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06978096608803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06978096608803069780966088036978096608803

GMDN Terms

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

Regulatory Flags

DUNS number
526968903
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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
06978096608896KYTOKYTO28802025-02-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850080488249flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-03-06
16974308960209Retone, NebrooXiamen Retone Hearing Technology Co., LtdQUG2026-02-05
00850080488140flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-01-16
05714880290356hear.comWs Audiology Usa, Inc.QUG2026-01-12
16974308960193Retone Xiamen Retone Hearing Technology Co., LtdQUG2026-01-08
06977352080438ELEHEARELEHEAR Inc.QUG2025-12-31
06943786079911AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2025-12-03
05708296386239GN HearingGn Hearing A/SQUG2025-09-21
05708296386246GN HearingGn Hearing A/SQUG2025-09-21
05708296391240GN HearingGn Hearing A/SQUG2025-09-21
05708296386253GN HearingGn Hearing A/SQUG2025-09-19
05708296386260GN HearingGn Hearing A/SQUG2025-09-19
05708296386277GN HearingGn Hearing A/SQUG2025-09-19
05708296386284GN HearingGn Hearing A/SQUG2025-09-19
05708296386291GN HearingGn Hearing A/SQUG2025-09-19
05708296386307GN HearingGn Hearing A/SQUG2025-09-19
05708296386314GN HearingGn Hearing A/SQUG2025-09-19
05708296386321GN HearingGn Hearing A/SQUG2025-09-19
05708296386338GN HearingGn Hearing A/SQUG2025-09-19
05708296386345GN HearingGn Hearing A/SQUG2025-09-19
05708296386352GN HearingGn Hearing A/SQUG2025-09-19
05708296386369GN HearingGn Hearing A/SQUG2025-09-19
05708296386376GN HearingGn Hearing A/SQUG2025-09-19
05708296391189GN HearingGn Hearing A/SQUG2025-09-19
05708296391196GN HearingGn Hearing A/SQUG2025-09-19
05708296391202GN HearingGn Hearing A/SQUG2025-09-19
05708296391219GN HearingGn Hearing A/SQUG2025-09-19
05708296391226GN HearingGn Hearing A/SQUG2025-09-19
05708296391233GN HearingGn Hearing A/SQUG2025-09-19
05708296391257GN HearingGn Hearing A/SQUG2025-09-19