Gynius AB

Address:Jarnbrotts Prastvag 2,Gothenburg Vastra Gotaland,SE

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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

Colposcope (And Colpomicroscope) (HEX) (1)

Premarket Exempt

Clear

Gynius - 07300009046461 Catalog Number : GYN-0001

Device Description : The Gynocular is a colposcope intended to provide magnified visualization for th The Gynocular is a colposcope intended to provide magnified visualization for the tissues of the vagina, cervix and the external genitalia. It Is used to evaluate these tissues and select areas for biopsy.

Device Class : 2

Duns Number: 777393922

Premarket Exempt : No

Product Code : HEX

Prescription Use : No

Device Count : 1

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