Identity
- Device Name
- Ava Fertility Tracker EUDAMED
- Model / Reference
- 1.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08720892341501 EUDAMED
- Basic UDI-DI
- 87208923415AvaFTGX EUDAMED
- EMDN Code
- Z12080292 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Ava Fertility Tracker by Awesome Health — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 87208923415AvaFTGX | Class I | Active |
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Manufacturer
- Manufacturer
- Awesome Health
- EUDAMED SRN
- US-MF-000039676
- Authorised Representative
- SigmaTech Nordic ApS DK-AR-000039264
Sources (1)
- EUDAMED 115c8867-37d8-4cf2-8bf1-5480f6fcd0ca 61 fields · synced Jun 18, 2026