gudid Primary ID: BS50-500

miniPhantom (UDI BS50-500)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The miniPhantom (Model/Catalog Number: BS50-500) is a medical device manufactured by IBA Dosimetry GmbH. This product is indexed under FDA Product Code / Category Classification IXG within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1703-2025 View Full Alert →

myQA iON; Article Number: MQ10-000;...

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Technical Specifications

Model Number: BS50-500
Product Code / EMDN: IXG
Device Name: Solid Phantom, miniPhantom
Database Sync Date: 2026-08-09 09:08:29

Full Regulatory Attributes

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{
    "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 miniPhantom?

The registered manufacturer of record for miniPhantom is IBA Dosimetry GmbH.

What is the Primary UDI-DI identifier for miniPhantom?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BS50-500.

What classification code is assigned to this device?

This device is registered under product classification code IXG.

Similar Classification Devices (IXG)

Other Devices by IBA Dosimetry GmbH

Programmatic Export

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