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Ava Fertility Tracker - EUDAMED Registration 08720892341501

Access comprehensive regulatory information for Ava Fertility Tracker in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 08720892341501 and manufactured by Awesome Health in United States.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Danish Medicines Agency, Pharmacovigilance & Medical Devices), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class I
08720892341501
Yes
Ava Fertility Tracker
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12080292
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08720892341501
Basic UDI
87208923415AvaFTGX
Version Date
January 25, 2024
Manufacturer Last Update
January 18, 2024
Active Status
Yes
Manufacturer
Manufacturer Name
Awesome Health
Country
United States
Country Type
NON_EU
Address
1018 3964 Rivermark Plz Santa Clara
Email
info@awesome-health.com
Authorized Representative
SRN
DK-AR-000039264
Country
Denmark
Address
36 Ringholmvej Broenshoej
Email
info@sigmatechnordic.com
Regulatory Information
Competent Authority
Danish Medicines Agency, Pharmacovigilance & Medical Devices
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No