MOBILEODT LTD

Address:Ben Avigdor 8, 3rd Floor,Tel Aviv,IL

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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

Colposcope (And Colpomicroscope) (HEX) (3)

Premarket Exempt

Clear

EVA System - 17290016976004 Catalog Number :

Device Description : The EVA (Enhanced Visual Assessment) System is intended to provide magnified vie The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remoteviewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.

Device Class : 2

Duns Number: 600049276

Premarket Exempt : No

Product Code : HEX

Prescription Use : Yes

Device Count : 1

EVA System - 17290016976011 Catalog Number :

Device Class : 2

Duns Number: 600049276

Premarket Exempt : No

Product Code : HEX

Prescription Use : Yes

Device Count : 1

EVA System - 17290016976028 Catalog Number :

Device Class :

Duns Number: 600049276

Premarket Exempt : No

Product Code : HEX

Prescription Use : Yes

Device Count : 1

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