GUDIDData
eudamed_udi Primary ID: 04004221064588

Bi-Grip (UDI 04004221064588)

Manufactured by KOB GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Bi-Grip - Primary ID 04004221064588

Device Regulatory Overview

The Bi-Grip (Model/Catalog Number: HBI2010) is a medical device manufactured by KOB GmbH. This product is indexed under FDA Product Code / Category Classification M03030103 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...

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Technical Specifications

Model Number
HBI2010
Product Code / EMDN
M03030103
Device Name
911
Database Sync Date
2026-08-09 16:28:52

Full Regulatory Attributes

🔒 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 Bi-Grip?

The registered manufacturer of record for Bi-Grip is KOB GmbH.

What is the Primary UDI-DI identifier for Bi-Grip?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04004221064588.

What classification code is assigned to this device?

This device is registered under product classification code M03030103.

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