Identity
- Trade Name
- AutoDensity EUDAMED
- Device Name
- AutoDensity EUDAMED
- Model / Reference
- AutoDensity EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03663999000344 EUDAMED
- Basic UDI-DI
- 3663999BMD01XZ EUDAMED
- Direct Marketing DI
- 03663999000344 EUDAMED
- EMDN Code
- Z11900192 BONE DENSITOMETRY SYSTEMS - 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
AutoDensity by Eos Imaging — 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 | K251078 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 3663999BMD01XZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- EOS imaging
- EUDAMED SRN
- FR-MF-000000502
Sources (2)
- EUDAMED c0da0b82-9de2-4831-a988-aea7ab980c00 61 fields · synced Sep 17, 2026
- FDA 510(k) K251078 1 fields · synced May 18, 2026