eudamed_udi Primary ID: 04251978600549

PC-Software OR5 (UDI 04251978600549)

Manufactured by Dr. Fenyves und Gut Deutschland GmbH

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

Scannable UDI-DI Representation

Device Regulatory Overview

The PC-Software OR5 (Model/Catalog Number: 925306) is a medical device manufactured by Dr. Fenyves und Gut Deutschland GmbH. This product is indexed under FDA Product Code / Category Classification Z12100582 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 925306
Product Code / EMDN: Z12100582
Device Name: PC-Software OR5
Database Sync Date: 2026-08-09 16:29:34

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 PC-Software OR5?

The registered manufacturer of record for PC-Software OR5 is Dr. Fenyves und Gut Deutschland GmbH.

What is the Primary UDI-DI identifier for PC-Software OR5?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04251978600549.

What classification code is assigned to this device?

This device is registered under product classification code Z12100582.

Similar Classification Devices (Z12100582)

Other Devices by Dr. Fenyves und Gut Deutschland GmbH

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