eudamed_udi Primary ID: 04542187218862

Zelf－Katheterisatie Set (Type Man-L) (UDI 04542187218862)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Zelf－Katheterisatie Set (Type Man-L) (Model/Catalog Number: 800-001-5982H) 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: 800-001-5982H
Product Code / EMDN: U010199
Device Name: Self-Catheterization Set
Database Sync Date: 2026-08-09 16:47:27

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 Zelf－Katheterisatie Set (Type Man-L)?

The registered manufacturer of record for Zelf－Katheterisatie Set (Type Man-L) is CREATE MEDIC CO., LTD..

What is the Primary UDI-DI identifier for Zelf－Katheterisatie Set (Type Man-L)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04542187218862.

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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