Identity
- Trade Name
- CadOne EUDAMED
- Device Name
- CadOne EUDAMED
- Model / Reference
- 3.2.6 EUDAMEDCAD1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B148CADONE3260 EUDAMED
- Basic UDI-DI
- ++B148CADONE3260VK EUDAMED
- Direct Marketing DI
- B148CADONE3260 EUDAMED
- EMDN Code
- Z11030292 MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CadOne by Three Palm Software — Class I — 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 | ++B148CADONE3260VK | Class I | Active |
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Manufacturer
- Manufacturer
- Three Palm Software
- EUDAMED SRN
- US-MF-000002924
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 737f18dc-b195-4cd1-946c-5e1e1c691e94 61 fields · synced Jun 18, 2026