GUDIDData
gudid Primary ID: 03289796190

free PSA Calset (UDI 03289796190)

Manufactured by Roche Diagnostics GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for free PSA Calset - Primary ID 03289796190

Device Regulatory Overview

The free PSA Calset (Model/Catalog Number: 03289796190) is a medical device manufactured by Roche Diagnostics GmbH. This product is indexed under FDA Product Code / Category Classification MTG within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
03289796190
Product Code / EMDN
MTG
Device Name
free PSA CalSet-calibrator
Database Sync Date
2026-08-09 09:44:46

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 free PSA Calset?

The registered manufacturer of record for free PSA Calset is Roche Diagnostics GmbH.

What is the Primary UDI-DI identifier for free PSA Calset?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 03289796190.

What classification code is assigned to this device?

This device is registered under product classification code MTG.

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