FERTILITY FOCUS LIMITED

FERTILITY FOCUS LIMITED

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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

Device, Fertility Diagnostic, Proceptive (LHD) (6) Culdoscope (And Accessories) (HEW) (1) Hysteroscope (And Accessories) (HIH) (1) Laparoscope, Gynecologic (And Accessories) (HET) (1)

Premarket Exempt

No Yes

Clear

OvuSense - 05060508530039 Catalog Number :

Device Description : M300 OvuCore Starter Pack - M026 OvuCore Vaginal Sensor and M032 OvuSense App

Device Class : U

Duns Number: 347449352

Premarket Exempt : Yes

Product Code : LHD

Prescription Use : No

Device Count : 1

FertiloScope - 05060508530046 Catalog Number :

Device Description : Transvaginal Cannula with its pointed trocar, devised for introduction in the po Transvaginal Cannula with its pointed trocar, devised for introduction in the pouch of Douglas in order to perform a Transvaginal hydro-pelviscopy

Device Class : 2

Duns Number: 347449352

Premarket Exempt : No

Product Code : HIH, HEW, HET

Prescription Use : No

Device Count : 1

OvuSense - 05060508530053 Catalog Number :

Device Description : M026 OvuCore Vaginal Sensor

Device Class : U

Duns Number: 347449352

Premarket Exempt : Yes

Product Code : LHD

Prescription Use : No

Device Count : 1

OvuSense - 05060508530091 Catalog Number :

Device Description : M426 OvuFirst Skin Worn Sensor

Device Class : U

Duns Number: 347449352

Premarket Exempt : Yes

Product Code : LHD

Prescription Use : No

Device Count : 1

OvuSense - 05060508530107 Catalog Number :

Device Description : OvuSense 2 App - iOS

Device Class : U

Duns Number: 347449352

Premarket Exempt : Yes

Product Code : LHD

Prescription Use : No

Device Count : 1

OvuSense - 05060508530114 Catalog Number :

Device Description : OvuSense 2 App - Android

Device Class : U

Duns Number: 347449352

Premarket Exempt : Yes

Product Code : LHD

Prescription Use : No

Device Count : 1

OvuSense - 05060508530121 Catalog Number :

Device Description : M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App

Device Class : U

Duns Number: 347449352

Premarket Exempt : Yes

Product Code : LHD

Prescription Use : No

Device Count : 1

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