INVENTIS SRL

Address:Corso Stati Uniti 1/3,Padova,IT

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Audiometer (EWO) (2) Calibrator, Hearing Aid / Earphone And Analysis Systems (ETW) (2) Tester, Auditory Impedance, Exempt (PTO) (1)

Premarket Exempt

Yes

Clear

TRUMPET - 08054187380624 Catalog Number : 11167

Device Description : The kit includes loudspeaker, coupler, microphone, and the adapters in order to The kit includes loudspeaker, coupler, microphone, and the adapters in order to perform RECD measurements on different types of hearing aids.

Device Class : 2

Duns Number: 338454995

Premarket Exempt : Yes

Product Code : ETW

Prescription Use : Yes

Device Count : 1

DRUM - 08054187380730 Catalog Number : 11239

Device Description : Drum is a hearing instrument test box (HIT), with a high ambient noise attenuati Drum is a hearing instrument test box (HIT), with a high ambient noise attenuation level, capable of performing all the tests aimed at hearing aids analysis via air conduction.

Device Class : 2

Duns Number: 338454995

Premarket Exempt : Yes

Product Code : ETW

Prescription Use : Yes

Device Count : 1

TIMPANI - 08054187380747 Catalog Number : 11440

Device Description : MIDDLE EAR ANALYZER / AUDIOMETER.Timpani is a portable middle ear analyzer / aud MIDDLE EAR ANALYZER / AUDIOMETER.Timpani is a portable middle ear analyzer / audiometer, capable of performing tympanometry.With additional licenses, it can perform acoustic ipsi-reflex tests in sequence and automatically and pure tone audiometry using air conduction.

Device Class : 2

Duns Number: 338454995

Premarket Exempt : Yes

Product Code : PTO, EWO

Prescription Use : Yes

Device Count : 1

TRIANGLE - 08054187380778 Catalog Number : 11689

Device Description : AUDIOMETER.Screening audiometer, capable of performing fast and accurate air and AUDIOMETER.Screening audiometer, capable of performing fast and accurate air and bone conduction threshold examination and screening test.

Device Class : 2

Duns Number: 338454995

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : Yes

Device Count : 1

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