GUDIDData
eudamed_udi Primary ID: 08680853112994

SILICONE INSOLES - FABRIC COATED-XL (UDI 08680853112994)

Manufactured by HEGELİ ORTOPEDİK ÜRÜNLER SAN.LTD.ŞTİ

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SILICONE INSOLES - FABRIC COATED-XL - Primary ID 08680853112994

Device Regulatory Overview

The SILICONE INSOLES - FABRIC COATED-XL (Model/Catalog Number: ARF01K-XL) is a medical device manufactured by HEGELİ ORTOPEDİK ÜRÜNLER SAN.LTD.ŞTİ. This product is indexed under FDA Product Code / Category Classification Y061203 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
ARF01K-XL
Product Code / EMDN
Y061203
Device Name
FOOT CARE
Database Sync Date
2026-08-09 16:28:50

Full Regulatory Attributes

🔒 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 SILICONE INSOLES - FABRIC COATED-XL?

The registered manufacturer of record for SILICONE INSOLES - FABRIC COATED-XL is HEGELİ ORTOPEDİK ÜRÜNLER SAN.LTD.ŞTİ.

What is the Primary UDI-DI identifier for SILICONE INSOLES - FABRIC COATED-XL?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08680853112994.

What classification code is assigned to this device?

This device is registered under product classification code Y061203.

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