Identity
- Trade Name
- Ava Fertility EUDAMEDFDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, reusable FDA UDI
- Device Name
- Ava Fertility EUDAMEDAva 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. FDA UDI
- Model / Reference
- PNA00046 EUDAMED2.1 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- PNA00046 FDA UDI
- Primary DI / UDI-DI
- 07640184680464 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018468AVATTC000153 EUDAMED
- Direct Marketing DI
- 07640184680464 EUDAMED
- FDA Product Code
- LHD FDA UDI
- EMDN Code
- Z12040199 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Wearable multiple physiological parameter recorder, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ava Fertility by Ava AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764018468AVATTC000153 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ava AG
- EUDAMED SRN
- CH-MF-000019137
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 0240ff67-0908-4feb-95a2-4d9c01645eff 61 fields · synced Jul 18, 2026
- FDA UDI 66a5567a-fddd-4b23-8b58-0a83d1bc91a3 35 fields · synced May 30, 2026