Identity
- Trade Name
- X-BEAM EUDAMED
- Device Name
- X-BEAM EUDAMED
- Model / Reference
- X-BEAM EUDAMED
Identifiers
- Primary DI / UDI-DI
- B850033600050 EUDAMED
- Basic UDI-DI
- ++B85003360005CK EUDAMED
- EMDN Code
- Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
X-Beam by Gilardoni Spa — Class IIb — 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 | ++B85003360005CK | Class IIb | Active |
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Manufacturer
- Manufacturer
- Gilardoni SPA
- EUDAMED SRN
- IT-MF-000008874
Sources (1)
- EUDAMED cf6aab75-b3be-4303-8088-e2847d9fc966 61 fields · synced Jun 18, 2026