eudamed_udi Primary ID: 04542187220643

Silicone Katheter voor Zelf-Katherisatie (Type Vrouw) (UDI 04542187220643)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Silicone Katheter voor Zelf-Katherisatie (Type Vrouw) (Model/Catalog Number: 04-5216H) is a medical device manufactured by CREATE MEDIC CO., LTD.. This product is indexed under FDA Product Code / Category Classification U010199 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 04-5216H
Product Code / EMDN: U010199
Device Name: Self-Catheterization Set
Database Sync Date: 2026-08-09 16:50:12

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 Silicone Katheter voor Zelf-Katherisatie (Type Vrouw)?

The registered manufacturer of record for Silicone Katheter voor Zelf-Katherisatie (Type Vrouw) is CREATE MEDIC CO., LTD..

What is the Primary UDI-DI identifier for Silicone Katheter voor Zelf-Katherisatie (Type Vrouw)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04542187220643.

What classification code is assigned to this device?

This device is registered under product classification code U010199.

Similar Classification Devices (U010199)

Other Devices by CREATE MEDIC CO., LTD.

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