MIEUX LLC

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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

Cup, Menstrual (HHE) (1)

Premarket Exempt

Yes

Clear

EllaCup - 00868609000216 Catalog Number :

Device Description : A cup-like receptacle placed by the user into the vagina to collect blood and ce A cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device.

Device Class : 2

Duns Number: 044916599

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

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