FDA.reportPublic FDA data

HARP

Primary DI
08054187380068
Brand
HARP
Company
INVENTIS SRL
Model
HARP PLUS
Catalog number
10146
Device description
AUDIOMETER.Harp Plus is an advanced diagnostic audiometer, capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; and certain supra-threshold tests.
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054187380068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054187380068080541873800688054187380068

GMDN Terms#

Term, Definition table
TermDefinition
Tone audiometerAn electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39 0498962844sales@inventis.it

Regulatory Flags#

DUNS number
338454995
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054187381232easyTympeasyTymp124672026-04-23
08054187381249easyTymp Docking StationeasyTymp Docking Station124682026-04-23
08054187380815Synapsys VHITSynapsys VHIT Basic107382025-01-08
08054187380822Synapsys VHITSynapsys VHIT Plus107392025-01-08
08054187380983VNGVNG BASIC WIRELESS114632024-10-01
08054187380990VNGVNG BASIC WIRELESS - XPR11463-XPR2024-10-01
08054187381003VNGVNG PLUS WIRELESS114642024-10-01
08054187381010VNGVNG PLUS WIRELESS - XPR 11464-XPR2024-10-01
08054187381027VNGVNG BASIC WIRED106192024-10-01
08054187381034VNGVNG PLUS WIRED106202024-10-01
08054187381041VNGVIDEO-SCOPE WIRELESS114472024-10-01
08054187381058VNGVIDEO-SCOPE WIRELESS - XPR11447-XPR2024-10-01
08054187381065VNGVIDEO-SCOPE WIRED119612024-10-01
08054187381140HARMONICAHARMONICA112052023-12-11
08054187380730DRUMDRUM112392017-08-24
08054187380020BELLBELL PLUS101442016-09-17
08054187380044HARPHARP BASIC101452016-09-17
08054187380051HARPHARP BASIC WITH PRINTER101622016-09-17
08054187380075HARPHARP PLUS WITH PRINTER101632016-09-17
08054187380082PIANOPIANO BASIC101472016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810046707180Grason-StadlerDiagnostic Group LLCEWO2026-04-06
057117810041053000 Real EarAuditdata A/SEWO2026-01-23
057117810041363000 Real EarAuditdata A/SEWO2026-01-23
057117810041433000 Real EarAuditdata A/SEWO2026-01-23
057117810041503000 Real EarAuditdata A/SEWO2026-01-23
057117810041673000 Real EarAuditdata A/SEWO2026-01-23
057117810041743000 Real EarAuditdata A/SEWO2026-01-23
B43056000011110GoCheckGobiquity, Inc.EWO2026-01-09
B43056000011100GoCheckGobiquity, Inc.EWO2025-12-02
05060753520090Tympa Otoscope SystemTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
05711781004204Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004211Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004228Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004235Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004242Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004259Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004266Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004280Measure by OtometricsAuditdata A/SEWO2025-11-14
05711117230833Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230840Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230857Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230864Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245097Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245103Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245110Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245127Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
04260223147326nanoAudio DD45PATH medical GmbHEWO2025-08-05
04260223147333nanoAudio DD65v2PATH medical GmbHEWO2025-08-05
04260223147340nanoAudio Patient Response ButtonPATH medical GmbHEWO2025-08-05