GUDIDData
gudid Primary ID: PROBEAT

PROBEAT (UDI PROBEAT)

Manufactured by HITACHI HIGH-TECH CORPORATION

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PROBEAT - Primary ID PROBEAT

Device Regulatory Overview

The PROBEAT (Model/Catalog Number: PROBEAT) is a medical device manufactured by HITACHI HIGH-TECH CORPORATION. This product is indexed under FDA Product Code / Category Classification LHN within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
PROBEAT
Product Code / EMDN
LHN
Device Name
The PROBEAT is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Database Sync Date
2026-08-09 09:15:39

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 PROBEAT?

The registered manufacturer of record for PROBEAT is HITACHI HIGH-TECH CORPORATION.

What is the Primary UDI-DI identifier for PROBEAT?

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

What classification code is assigned to this device?

This device is registered under product classification code LHN.

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