GUDIDData
eudamed_udi Primary ID: 08585003409835

Neoprénová bandáž kolena, KO-4 (UDI 08585003409835)

Manufactured by PROTETIKA, a.s.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Neoprénová bandáž kolena, KO-4 - Primary ID 08585003409835

Device Regulatory Overview

The Neoprénová bandáž kolena, KO-4 (Model/Catalog Number: 8585003409835) is a medical device manufactured by PROTETIKA, a.s.. This product is indexed under FDA Product Code / Category Classification Y061209 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
8585003409835
Product Code / EMDN
Y061209
Device Name
Knee orthose
Database Sync Date
2026-08-09 16:28:52

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 Neoprénová bandáž kolena, KO-4?

The registered manufacturer of record for Neoprénová bandáž kolena, KO-4 is PROTETIKA, a.s..

What is the Primary UDI-DI identifier for Neoprénová bandáž kolena, KO-4?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08585003409835.

What classification code is assigned to this device?

This device is registered under product classification code Y061209.

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