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ProBeam® Proton Therapy System Fixed Beam Room 4.3

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref ProBeam 4.3

by Varian Medical Systems Particle Therapy GmbH & Co. KG

Identity

Trade Name
ProBeam® Proton Therapy System Fixed Beam Room 4.3 EUDAMED
ProBeam® Proton Therapy System - Fixed Beam Room FDA UDI
Generic Name
Proton therapy system FDA UDI
Device Name
ProBeam, ProBeam 360° EUDAMED
Model / Reference
ProBeam 4.3 EUDAMED
4.3 FDA UDI

Identifiers

Primary DI / UDI-DI
00858991006064 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 EUDAMED
Class 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 Fixed Beam Room 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

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Manufacturer

Manufacturer
Varian Medical Systems Particle Therapy GmbH & Co. KG
EUDAMED SRN
DE-MF-000005626

Sources (2)

  • EUDAMED 9d63d65f-c327-481a-ac87-7e30ce27c9f4 61 fields · synced Oct 7, 2026
  • FDA UDI 746dadfe-be8d-4151-9420-bb52a1ae86b1 33 fields · synced May 30, 2026