FDA.reportPublic FDA data

Tympa Otoscope System

Primary DI
15060753520004
Brand
Tympa Otoscope System
Company
TYMPA HEALTH TECHNOLOGIES LIMITED
Model
iPhone XR
Published
2025-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ERAOtoscope
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060753520004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506075352000415060753520004

GMDN Terms#

Term, Definition table
TermDefinition
Video otoscope/audiometerAn electrically-powered portable device intended for the visual examination of the outer ear canal/tympanic membrane by video otology, and basic evaluation of hearing function. It consists of a speculum with integrated video camera, light source, pitch generator (speaker), and a dedicated smartphone for image display and data relay to a central datastore; it may provide a conduit for a microsuction device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
223449035
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060753520090Tympa Otoscope SystemiPhone 132025-11-19
05060753520106Otoscope AssemblyiPhone 132025-11-19
05060753520113Otoscope Assembly Charging StandiPhone 132025-11-19
25060753520018Otoscope AssemblyiPhone XR2025-02-04
25060753520025Otoscope Assembly Charging StandiPhone XR2025-02-04
25060753520063Tympa CloudTympa Cloud2025-02-04
25060753520070Tympa Mobile AppiOS2025-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817020020280Capella2 OAE Start-Up KitINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
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00817020021010B81 Bone Vibrator CableINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021164Bone Vibrator w/Cable and Headband (B81) for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021171Bone Vibrator Cable for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
05745000311064OscillaOscilla A/SEWO2026-05-29
05745000311095OscillaOscilla A/SEWO2026-05-29
05745000311156OscillaOscilla A/SEWO2026-05-29
05745000311163OscillaOscilla A/SEWO2026-05-29
05745000311187OscillaOscilla A/SEWO2026-05-29
05745000311200OscillaOscilla A/SEWO2026-05-29
16972545090017JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
16972545090031JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
00050428029497CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
25060753520063Tympa CloudTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-02-04
25060753520070Tympa Mobile AppTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-02-04
B43071000020GoCheck MultiScreenerGobiquity, Inc.EWO2024-09-23
KTS0025716K.T.SurgicoK.T.SURGICOERA2024-07-24
00817020021126AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2024-03-11
00311917035000WalgreensWALGREEN CO.ERA2023-11-01
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.ERA2023-10-15
00627908020192Bone ConductorVivosonic IncEWO2023-06-12
10884389104514MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21
10884389104521MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21
08054187380761TIMPANI DOCKING STATIONINVENTIS SRLEWO2023-01-04
17290018446154Nonagon N9+NONAGON LTDERA2022-09-28
27290018446151Nonagon N9+ SmartExamNONAGON LTDERA2022-09-28
M368122711LABTRONGF HEALTH PRODUCTS, INC.ERA2020-09-15