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

UltuCup - 00627987564013 Catalog Number :

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

UltuCup - 00627987564020 Catalog Number :

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

UltuCup - 00627987564037 Catalog Number :

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

UltuCup - 00627987564044 Catalog Number :

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

UltuCup - 00627987564051 Catalog Number :

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Eli Cup - 00689466237498 Catalog Number :

Device Description : Pre-childbirth, Light-to-medium flow

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Be Girl - 00816132022830 Catalog Number :

Device Description : Model 1 Standard

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

BeGirl - 00816132023059 Catalog Number :

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Casco Cup - 00850004683040 Catalog Number :

Device Description : Mid 42 Bell Menstrual Cup

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Casco Cup - 00850004683057 Catalog Number :

Device Description : Mid 47 Bell Menstrual Cup

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

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