Identity
- Trade Name
- MiniOmni EUDAMED
- Device Name
- MiniOmni EUDAMED
- Model / Reference
- MiniOmni EUDAMED001-0608 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-IL-MF-000015561YG EUDAMED
- Basic UDI-DI
- B-IL-MF-000015561YG EUDAMED
- EMDN Code
- Z11900102 ULTRASOUND BONE DENSITOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MiniOmni by BeamMed Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-IL-MF-000015561YG | Class IIa | Active |
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Manufacturer
- Manufacturer
- BeamMed Ltd.
- EUDAMED SRN
- IL-MF-000015561
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 4850a96f-f0d7-4627-a1c8-1aaeffcf0afa 61 fields · synced May 23, 2026