gudid Primary ID: KZ1030H3

Single-use Balloon Dilatation Catheter (UDI KZ1030H3)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Single-use Balloon Dilatation Catheter (Model/Catalog Number: KZ1030H3) is a medical device manufactured by Leo Medical Co., Ltd.. This product is indexed under FDA Product Code / Category Classification FGE within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: KZ1030H3
Product Code / EMDN: FGE
Device Name
Database Sync Date: 2026-08-09 09:04:54

Full Regulatory Attributes

🔒 Token Gated

{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of Single-use Balloon Dilatation Catheter?

The registered manufacturer of record for Single-use Balloon Dilatation Catheter is Leo Medical Co., Ltd..

What is the Primary UDI-DI identifier for Single-use Balloon Dilatation Catheter?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is KZ1030H3.

What classification code is assigned to this device?

This device is registered under product classification code FGE.

Similar Classification Devices (FGE)

Other Devices by Leo Medical Co., Ltd.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint