XPERT80
Ref XPERT80
XPERT80 is a medical device (EU MDR Class I; EMDN category multifunctional systems for direct digital radiology) made by Kub Technologies Inc, registered in EUDAMED on 23 Jan 2026 (Basic UDI-DI ++B619XSERIESBC), active as of 25 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++B619XSERIESBC +B619X801O | Date23 Jan 2026 | StatusActive |
Official records
- EUDAMED public site ++B619XSERIESBC
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- Withdrawn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
- Device name
- XPERT Series Tissue Specimen X-ray System
- Model / reference
- XPERT80
- Primary DI / UDI-DI
- +B619X801O
- Basic UDI-DI
- ++B619XSERIESBC
- Direct marketing DI
- +B619X801O
- EMDN code
- Z11031101 Multifunctional systems for direct digital radiology
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- US-MF-000026338
- Authorised representative
- Advena Limited MT-AR-000000234
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