Identity
- Trade Name
- HealthOST EUDAMED
- Device Name
- HealthOST EUDAMED
- Model / Reference
- 1.1 EUDAMEDHealthOST 1.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290018016121 EUDAMED
- Basic UDI-DI
- 7290018016HealthOST2L EUDAMED
- EMDN Code
- Z11900192 BONE DENSITOMETRY SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
HealthOST by Nano-X AI Ltd. — Class IIa — 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 | 7290018016HealthOST2L | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nano-X AI Ltd.
- EUDAMED SRN
- IL-MF-000010234
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 2284bff5-f00f-45ce-a410-88514412627e 61 fields · synced May 23, 2026