GUDIDData
gudid Primary ID: 3040-7201-0099

Add Pack Hemo Control DM (UDI 3040-7201-0099)

Manufactured by EKF-diagnostic GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Add Pack Hemo Control DM - Primary ID 3040-7201-0099

Device Regulatory Overview

The Add Pack Hemo Control DM (Model/Catalog Number: 3040-7201-0099) is a medical device manufactured by EKF-diagnostic GmbH. This product is indexed under FDA Product Code / Category Classification GKR within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
3040-7201-0099
Product Code / EMDN
GKR
Device Name
For the quantitative determination of hemoglobin in whole blood.
Database Sync Date
2026-08-09 10:02:15

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 Add Pack Hemo Control DM?

The registered manufacturer of record for Add Pack Hemo Control DM is EKF-diagnostic GmbH.

What is the Primary UDI-DI identifier for Add Pack Hemo Control DM?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 3040-7201-0099.

What classification code is assigned to this device?

This device is registered under product classification code GKR.

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