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ProBeam® Proton Therapy System Rotating Gantry 4.3
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ProBeam 4.3
Identity
- Trade Name
- ProBeam® Proton Therapy System Rotating Gantry 4.3 EUDAMEDProBeam® Proton Therapy System - Rotating Gantry FDA UDI
- Generic Name
- Proton therapy system FDA UDI
- Device Name
- ProBeam, ProBeam 360° EUDAMED
- Model / Reference
- ProBeam 4.3 EUDAMED4.3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858991006057 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200101PA EUDAMED
- 510(k) Number
- K133191 FDA UDI
- FDA Product Code
- LHN FDA UDI
- EMDN Code
- Z11011001 PROTON THERAPY SYSTEMS EUDAMED
- GMDN Term
- Proton therapy system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ProBeam® Proton Therapy System Rotating Gantry 4.3 by Varian Medical Systems Particle Therapy GmbH & Co. KG — Class IIb — MDR, FDA UDI — listed in EUDAMED…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 089947500200101PA | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- EUDAMED SRN
- DE-MF-000005626
Sources (2)
- EUDAMED 9c64d9cc-15d3-4362-881c-55e6f780920e 61 fields · synced Jun 18, 2026
- FDA UDI 1978912b-b8d8-408c-a2a3-0b2b39ded525 33 fields · synced May 30, 2026