Interacoustics A/S

Interacoustics A/S

Address:Audiometer Alle 1,Middelfart Syddanmark,DK

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Filters

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) (8) Calibrator, Hearing Aid / Earphone And Analysis Systems (ETW) (2) Stimulator, Auditory, Evoked Response (GWJ) (2) Tester, Auditory Impedance (ETY) (2) Electrode, Cutaneous (GXY) (1)

Premarket Exempt

No Yes

Clear

Interacoustics - 05711117070736 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : No

Product Code : ETW, EWO

Prescription Use : No

Device Count : 1

Interacoustics - 05711117076677 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : No

Product Code : GWJ, EWO

Prescription Use : No

Device Count : 1

Interacoustics - 05711117082104 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : No

Product Code : EWO, GWJ, ETY

Prescription Use : No

Device Count : 1

Interacoustics - 05711117089189 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : No

Product Code : ETW, EWO

Prescription Use : No

Device Count : 1

Interacoustics - 05711117101621 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

Sanibel - 05711117129687 Catalog Number :

Device Description : Pouch with 100 electrodes (10 cards with 10 each)

Device Class :

Duns Number: 306308354

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 100

Interacoustics - 05711117180206 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

Interacoustics - 05711117180213 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

Interacoustics - 05711117180244 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

Interacoustics - 05711117180251 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : No

Product Code : ETY

Prescription Use : No

Device Count : 1

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