GUDIDData
gudid Primary ID: Normal

HemoTrol Duo (UDI Normal)

Manufactured by Eurotrol B.V.

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

Device Regulatory Overview

The HemoTrol Duo (Model/Catalog Number: Normal) is a medical device manufactured by Eurotrol B.V.. This product is indexed under FDA Product Code / Category Classification GGM within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
Normal
Product Code / EMDN
GGM
Device Name
HemoTrol Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue Hb 301 and HemoCue Hb 801 System. HemoTrol Duo is intended for the quantitative determination of hemoglobin.
Database Sync Date
2026-08-09 09:26:45

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 HemoTrol Duo?

The registered manufacturer of record for HemoTrol Duo is Eurotrol B.V..

What is the Primary UDI-DI identifier for HemoTrol Duo?

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

What classification code is assigned to this device?

This device is registered under product classification code GGM.

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