GUDIDData
gudid Primary ID: 1

SURGIPLUS (UDI 1)

Manufactured by KENPAX INTERNATIONAL LIMITED

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SURGIPLUS - Primary ID 1

Device Regulatory Overview

The SURGIPLUS (Model/Catalog Number: 1) is a medical device manufactured by KENPAX INTERNATIONAL LIMITED. This product is indexed under FDA Product Code / Category Classification LYU within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
1
Product Code / EMDN
LYU
Device Name
Procedure Mask
Database Sync Date
2026-08-09 09:16:45

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 SURGIPLUS?

The registered manufacturer of record for SURGIPLUS is KENPAX INTERNATIONAL LIMITED.

What is the Primary UDI-DI identifier for SURGIPLUS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1.

What classification code is assigned to this device?

This device is registered under product classification code LYU.

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