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ProBeam Proton Therapy System - Eye Treatment Room
EUDAMEDClass IIb (EU MDR)
Ref ProBeam 4.3 MR6Ref ProBeam 4.3 MR4
Identity
- Trade Name
- ProBeam Proton Therapy System - Eye Treatment Room EUDAMED
- Device Name
- ProBeam, ProBeam 360° EUDAMED
- Model / Reference
- ProBeam 4.3 MR6 EUDAMEDProBeam 4.3 MR4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00858991006156 EUDAMED00858991006125 EUDAMED
- Basic UDI-DI
- 089947500200101PA EUDAMED
- EMDN Code
- Z11011001 PROTON THERAPY SYSTEMS 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
ProBeam Proton Therapy System - Eye Treatment Room by Varian Medical Systems Particle Therapy GmbH & Co. KG — Class IIb — MDR — listed in EUDAMED
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 | 089947500200101PA | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- DE-MF-000005626
Sources (2)
- EUDAMED 016eed5a-e831-48f7-8cca-603874e4f020 61 fields · synced Oct 6, 2026
- EUDAMED b028a2ac-bf16-4135-af7f-90c9982a50e2 61 fields · synced May 18, 2026