Identity
- Trade Name
- XPERT80L EUDAMED
- Device Name
- XPERT Series Tissue Specimen X-ray System EUDAMED
- Model / Reference
- XPERT80L EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B619X80L12 EUDAMED
- Basic UDI-DI
- ++B619XSERIESBC EUDAMED
- Direct Marketing DI
- +B619X80L12 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Category: Stationary basic diagnostic x-ray system, digital
Xpert80l by Kub Technologies Inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++B619XSERIESBC | Class I | Active |
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Manufacturer
- Manufacturer
- Kub Technologies Inc
- EUDAMED SRN
- US-MF-000026338
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 7b27d96e-da0e-436d-a35b-39a2b7a8cbfc 61 fields · synced Jun 17, 2026