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) (5) Device, External Penile Rigidity (LKY) (3) Perineometer (HIR) (2)

Premarket Exempt

No Yes

Clear

Lelo Tor 2 Black - 07350022271821 Catalog Number :

Device Description : External penile rigidity devices are devices intended to create or maintain suff

Device Class : 2

Duns Number: 508701849

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Lelo Tor 2 Purple - 07350022271838 Catalog Number :

Device Description : External penile rigidity devices are devices intended to create or maintain suff

Device Class : 2

Duns Number: 508701849

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Lelo Tor 2 Green - 07350022271845 Catalog Number :

Device Description : External penile rigidity devices are devices intended to create or maintain suff

Device Class : 2

Duns Number: 508701849

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Intimina Lily Cup Size A - EN - 07350022276093 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 Lily Cup Size B - EN - 07350022276109 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 Lily Cup Compact size A - EN - 07350022276116 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 KegelSmart - 07350022278004 Catalog Number :

Device Description : A perineometer is a device consisting of a fluid-filled sack for intravaginal us

Device Class : 2

Duns Number: 508701849

Premarket Exempt : No

Product Code : HIR

Prescription Use : No

Device Count : 1

Intimina KegelSmart - ML2(EN/IT/SV/FI) - 07350075020032 Catalog Number :

Device Description : A perineometer is a device consisting of a fluid-filled sack for intravaginal us

Device Class : 2

Duns Number: 508701849

Premarket Exempt : No

Product Code : HIR

Prescription Use : No

Device Count : 1

Intimina Lily Cup Compact size B - EN - 07350075020117 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 Lily Cup Compact Tamaño A - ES - 07350075020308 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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