GUDIDData
eudamed_udi Primary ID: 00858991006156

ProBeam Proton Therapy System - Eye Treatment Room (UDI 00858991006156)

Manufactured by Varian Medical Systems Particle Therapy GmbH & Co. KG

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ProBeam Proton Therapy System - Eye Treatment Room - Primary ID 00858991006156

Device Regulatory Overview

The ProBeam Proton Therapy System - Eye Treatment Room (Model/Catalog Number: ProBeam 4.3 MR6) is a medical device manufactured by Varian Medical Systems Particle Therapy GmbH & Co. KG. This product is indexed under FDA Product Code / Category Classification Z11011001 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
ProBeam 4.3 MR6
Product Code / EMDN
Z11011001
Device Name
ProBeam, ProBeam 360°
Database Sync Date
2026-08-09 18:13:22

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of ProBeam Proton Therapy System - Eye Treatment Room?

The registered manufacturer of record for ProBeam Proton Therapy System - Eye Treatment Room is Varian Medical Systems Particle Therapy GmbH & Co. KG.

What is the Primary UDI-DI identifier for ProBeam Proton Therapy System - Eye Treatment Room?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00858991006156.

What classification code is assigned to this device?

This device is registered under product classification code Z11011001.

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