GUDIDData
eudamed_udi Primary ID: 15414566580654

GAMMEX Non-Latex PI Underglove (UDI 15414566580654)

Manufactured by Ansell Healthcare Europe NV

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GAMMEX Non-Latex PI Underglove - Primary ID 15414566580654

Device Regulatory Overview

The GAMMEX Non-Latex PI Underglove (Model/Catalog Number: 340058065 Size 6.5) is a medical device manufactured by Ansell Healthcare Europe NV. This product is indexed under FDA Product Code / Category Classification T01010203 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
340058065 Size 6.5
Product Code / EMDN
T01010203
Device Name
Polyisoprene Surgical Gloves
Database Sync Date
2026-08-09 16:59:49

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 GAMMEX Non-Latex PI Underglove?

The registered manufacturer of record for GAMMEX Non-Latex PI Underglove is Ansell Healthcare Europe NV.

What is the Primary UDI-DI identifier for GAMMEX Non-Latex PI Underglove?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 15414566580654.

What classification code is assigned to this device?

This device is registered under product classification code T01010203.

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