Identity
- Trade Name
- FETOLY EUDAMED
- Device Name
- FETOLY EUDAMED
- Model / Reference
- FETOLY EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770033463031 EUDAMED03770033463048 EUDAMED
- Basic UDI-DI
- 3770033463FETOLYv2ZB EUDAMED
- Direct Marketing DI
- 03770033463031 EUDAMED03770033463048 EUDAMED
- EMDN Code
- Z12080192 PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fetoly by Diagnoly — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251368 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 3770033463FETOLYv2ZB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Diagnoly
- EUDAMED SRN
- FR-MF-000037822
Sources (3)
- EUDAMED 3884aa89-877c-411d-8dd7-15f854b93860 61 fields · synced Jul 16, 2026
- EUDAMED 89c9d031-7fcf-41dd-ad06-46db61011e20 61 fields · synced May 18, 2026
- FDA 510(k) K251368 1 fields · synced May 18, 2026