eudamed_udi Primary ID: 04542187229189

All Silicone Gastrostomy Balloon Catheter (Flat Balloon Type) (UDI 04542187229189)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The All Silicone Gastrostomy Balloon Catheter (Flat Balloon Type) (Model/Catalog Number: 800 000 2167) is a medical device manufactured by CREATE MEDIC CO., LTD.. This product is indexed under FDA Product Code / Category Classification G02020201 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 800 000 2167
Product Code / EMDN: G02020201
Device Name: All Silicone Gastrostomy Balloon Catheter
Database Sync Date: 2026-08-09 16:48:48

Full Regulatory Attributes

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{
    "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 All Silicone Gastrostomy Balloon Catheter (Flat Balloon Type)?

The registered manufacturer of record for All Silicone Gastrostomy Balloon Catheter (Flat Balloon Type) is CREATE MEDIC CO., LTD..

What is the Primary UDI-DI identifier for All Silicone Gastrostomy Balloon Catheter (Flat Balloon Type)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04542187229189.

What classification code is assigned to this device?

This device is registered under product classification code G02020201.

Similar Classification Devices (G02020201)

Other Devices by CREATE MEDIC CO., LTD.

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