GUDIDData
eudamed_udi Primary ID: 05060937940218

GEL OVATIONS EUROPE (UDI 05060937940218)

Manufactured by Gel Ovations Europe Limited

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GEL OVATIONS EUROPE - Primary ID 05060937940218

Device Regulatory Overview

The GEL OVATIONS EUROPE (Model/Catalog Number: 18205D) is a medical device manufactured by Gel Ovations Europe Limited. This product is indexed under FDA Product Code / Category Classification Y122499 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
18205D
Product Code / EMDN
Y122499
Device Name
GEL FILLED CUSHION
Database Sync Date
2026-08-09 16:29:15

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 GEL OVATIONS EUROPE?

The registered manufacturer of record for GEL OVATIONS EUROPE is Gel Ovations Europe Limited.

What is the Primary UDI-DI identifier for GEL OVATIONS EUROPE?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05060937940218.

What classification code is assigned to this device?

This device is registered under product classification code Y122499.

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