Identity
- Device Name
- HealthPNX+ EUDAMED
- Model / Reference
- Version 2.0 EUDAMEDTBD EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HealthPNX+UV EUDAMED
- Basic UDI-DI
- B-HealthPNX+UV EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- France 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
HealthPNX+ by Nano-X AI 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-HealthPNX+UV | 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 94e8d6bf-b398-4d06-9044-e11f5fca7933 61 fields · synced Jun 20, 2026