Leloi AB

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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) (4) Condom (HIS) (1)

Premarket Exempt

No Yes

Clear

HEX Condoms Respect 36 Pack (US_TNR) - 07350075025020 Catalog Number :

Device Description : The LELO RESPECT HEX Natural Rubber Latex Condom is used for contraception and f The LELO RESPECT HEX Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Device Class :

Duns Number: 508701849

Premarket Exempt : No

Product Code : HIS

Prescription Use : No

Device Count : 36

Intimina Lily Cup One - 07350075026065 Catalog Number :

Device Description : A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.

Device Class : 2

Duns Number: 508701849

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Intimina Ziggy Cup - 07350075026140 Catalog Number :

Device Description : A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.

Device Class : 2

Duns Number: 508701849

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Intimina Ziggy Cup 2 - Size B - 07350075028557 Catalog Number :

Device Description : A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.

Device Class : 2

Duns Number: 508701849

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Intimina Ziggy Cup 2 - Size A - 07350075028601 Catalog Number :

Device Description : A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.

Device Class : 2

Duns Number: 508701849

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

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