GUDIDData
gudid Primary ID: 04.0.27

IH-Com (UDI 04.0.27)

Manufactured by Bio-Rad Medical Diagnostics GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for IH-Com - Primary ID 04.0.27

Device Regulatory Overview

The IH-Com (Model/Catalog Number: 04.0.27) is a medical device manufactured by Bio-Rad Medical Diagnostics GmbH. This product is indexed under FDA Product Code / Category Classification KSZ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
04.0.27
Product Code / EMDN
KSZ
Device Name
IH-Com Kit Fullversion US; Software Version: 04.0.27.
Database Sync Date
2026-08-09 09:23:28

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 IH-Com?

The registered manufacturer of record for IH-Com is Bio-Rad Medical Diagnostics GmbH.

What is the Primary UDI-DI identifier for IH-Com?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04.0.27.

What classification code is assigned to this device?

This device is registered under product classification code KSZ.

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