CASCO BAY MOLDING LTD.

Address:32 Smada Dr,Sanford,ME,04073,US

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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) (10)

Premarket Exempt

Yes

Clear

myEverCup - B8390JNDAGCY2094980F40 Catalog Number :

Device Description : Size 1 Mid with Violet Cleaning Case

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

CascoCup - B8393P0NW4YVNYKYEV6DS0 Catalog Number :

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

OVACUP - B8393XPM7HDFHF29FC4800 Catalog Number :

Device Description : OVACUP Egg S Engraved Menstrual Cup

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

myEverCup - B8394F5BS5GTNE2FDC52C0 Catalog Number :

Device Description : Size Mini with Cloth Bag

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

myEverCup - B8397QJMD6N2Q2171C34A0 Catalog Number :

Device Description : Size 1 Mid with Cloth bag

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

myEverCup - B839842F766HT2D0589630 Catalog Number :

Device Description : Size 2 Standard with Cloth Bag

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Venus Cup - B8398JK1YC8XQEAC560780 Catalog Number :

Device Description : Venus Cup L Cup Violet

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

myEverCup - B839B7RW9NMMV783BC3AA0 Catalog Number :

Device Description : Size 1 Standard with Orange Cleaning Case

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

myEverCup - B839CA7ZCG9YCAFA25EDA0 Catalog Number :

Device Description : Size 2 Mid with Cloth Bag

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

myEverCup - B839DMRNTRQE6EDADE6FB0 Catalog Number :

Device Description : Size 1 Standard with Cloth Bag

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

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