GUDIDData
eudamed_udi Primary ID: 04542187223590

Zelf-katheterisatie Set PURE CATH (UDI 04542187223590)

Manufactured by CREATE MEDIC CO., LTD.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Zelf-katheterisatie Set PURE CATH - Primary ID 04542187223590

Device Regulatory Overview

The Zelf-katheterisatie Set PURE CATH (Model/Catalog Number: 800-000-9915) 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
800-000-9915
Product Code / EMDN
U010199
Device Name
Self-Catheterization Set
Database Sync Date
2026-08-09 16:48:41

Full Regulatory Attributes

πŸ”’ 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 Zelf-katheterisatie Set PURE CATH?

The registered manufacturer of record for Zelf-katheterisatie Set PURE CATH is CREATE MEDIC CO., LTD..

What is the Primary UDI-DI identifier for Zelf-katheterisatie Set PURE CATH?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04542187223590.

What classification code is assigned to this device?

This device is registered under product classification code U010199.

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