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

Venus Cup - B839DQBP5SBGC68E32BCE0 Catalog Number :

Device Description : Venus S Cup & Venus L Cup Violet

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

myEverCup - B839KZ20F2N9PK2CS8B5H0 Catalog Number :

Device Description : Size 1 Standard with Blue Cleaning Case

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Athena Club - B839N2K9Z3B2W88CDDD240 Catalog Number :

Device Description : Athena Club Mid Size 1 Menstrual Cup

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

myEverCup - B839NZXX6FYD9602885870 Catalog Number :

Device Description : Size 1 Mid with Orange Cleaning Case

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Venus Cup - B839Q4CJQDNSYF2B59D130 Catalog Number :

Device Description : Venus S Cup Violet

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

CascoCup - B839QG1A3R6BH9272A3170 Catalog Number :

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

OVACUP - B839R8Y3BK0VZE2CE39560 Catalog Number :

Device Description : OVACUP Egg L Engraved

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

CascoCup - B839T2YW19J3Y4B03F5980 Catalog Number :

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

myEverCup - B839W6983X41NCA53893A0 Catalog Number :

Device Description : Size 1 Standard with Violet Cleaning Case

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

myEverCup - B839WBWANSWY6FPTX7PBP0 Catalog Number :

Device Description : Size 1 Mid with Blue Cleaning Case

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

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