Fertility AI Tool
by Cercle.ai, Inc. United States EUDAMED
Ref Fertility AI Tool EMDN Z12080282
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++G731FertilityAIToolTQ | Date25 Mar 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Fertility AI Tool
- Model / Reference
- Fertility AI Tool
- Primary DI / UDI-DI
- +G731FERTILITYAITOOL0C
- Basic UDI-DI
- ++G731FertilityAIToolTQ
- EMDN Code
- Z12080282 Gynaecology and fertility treatment instruments - software accessories
- Device Class
- Class I
- Special Device Type
- Software
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- US-MF-000046227
- Authorised representative
- CERCLE.AI SPAIN SL ES-AR-000034889
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED ab98484a-0d1a-418e-adcd-eeda269e8f59