GUDIDData
Bulk Audit Tool API Access
eudamed_udi Primary ID: 04004221072842

Digitex + (UDI 04004221072842)

Manufactured by KOB GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Digitex + - Primary ID 04004221072842

Device Regulatory Overview

The Digitex + (Model/Catalog Number: 12010F) is a medical device manufactured by KOB GmbH. This product is indexed under FDA Product Code / Category Classification M030402020101 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1495-2026 View Full Alert →

MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010...

๐Ÿ”’ Compromised Lot & Serial Numbers Locked
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Technical Specifications

Model Number
12010F
Product Code / EMDN
M030402020101
Device Name
752
Database Sync Date
2026-08-09 16:50:41

Full Regulatory Attributes

๐Ÿ”’ Token Gated 
{
    "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 Digitex +?

The registered manufacturer of record for Digitex + is KOB GmbH.

What is the Primary UDI-DI identifier for Digitex +?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04004221072842.

What classification code is assigned to this device?

This device is registered under product classification code M030402020101.

Similar Classification Devices (M030402020101)

Other Devices by KOB GmbH

Programmatic Export

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JSON API Endpoint