Identity
- Trade Name
- Ava Fertility FDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, reusable FDA UDI
- Device Name
- 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
- Model / Reference
- 2.0 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
- PNA00013 FDA UDI
- Primary DI / UDI-DI
- 07640184680136 FDA UDI
- FDA Product Code
- LHD FDA UDI
- GMDN Term
- Wearable multiple physiological parameter recorder, reusable FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wearable multiple physiological parameter recorder, reusable
Ava Fertility by AVA Sciences-FMTC GmbH — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- AVA Sciences-FMTC GmbH
Sources (1)
- FDA UDI 6a6a3811-a5ad-495e-aebf-aa35334e9e08 35 fields · synced May 30, 2026