AVA Sciences-FMTC GmbH

Address:Gutstrasse 73,Zurich,CH

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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) (2)

Premarket Exempt

No Yes

Clear

Ava Fertility - 07640184680136 Catalog Number : PNA00013

Device Description : Ava Fertility is intended to measure and display physiological parameters (body Ava Fertility is intended to measure and display physiological parameters (body temperature, resting pulse rate, heart rate variability, and breathing rate) as an aid in ovulation prediction to facilitate conception (not to be used for contraception). It is a non-invasive device made up of a sensor bracelet, a mobile application and a backend system including the trying to conceive (TTC) algorithm.

Device Class : U

Duns Number: 480600727

Premarket Exempt : No

Product Code : LHD

Prescription Use : No

Device Count : 1

Ava Fertility - 07640184680464 Catalog Number : PNA00046

Device Class : U

Duns Number: 480600727

Premarket Exempt : Yes

Product Code : LHD

Prescription Use : No

Device Count : 1

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