CadOne
Ref CAD1Model 3.2.6
CadOne (CAD1) is a Class I device made by Three Palm Software, registered in EUDAMED on 9 Mar 2026 (Basic UDI-DI ++B148CADONE3260VK), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++B148CADONE3260VK B148CADONE3260 | Date9 Mar 2026 | StatusActive |
Official records
- EUDAMED public site ++B148CADONE3260VK
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- 3.2.6, CAD1
- Primary DI / UDI-DI
- B148CADONE3260
- Basic UDI-DI
- ++B148CADONE3260VK
- Direct marketing DI
- B148CADONE3260
- EMDN code
- Z11030292 Mammography systems - medical device software
- Device class
- Class I
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- US-MF-000002924
- Authorised representative
- Wellkang Ltd XI-AR-000001836
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