GUDIDData
eudamed_udi Primary ID: 04710374234562

Uni Fit ROM Knee Support (UDI 04710374234562)

Manufactured by e-life International Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Uni Fit ROM Knee Support - Primary ID 04710374234562

Device Regulatory Overview

The Uni Fit ROM Knee Support (Model/Catalog Number: MKNNP91 (Universal/UNI/BK)) is a medical device manufactured by e-life International Co., Ltd.. This product is indexed under FDA Product Code / Category Classification Y061209 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
MKNNP91 (Universal/UNI/BK)
Product Code / EMDN
Y061209
Device Name
Knee orthosis and tubular support bandage
Database Sync Date
2026-08-09 16:29:30

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 Uni Fit ROM Knee Support?

The registered manufacturer of record for Uni Fit ROM Knee Support is e-life International Co., Ltd..

What is the Primary UDI-DI identifier for Uni Fit ROM Knee Support?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04710374234562.

What classification code is assigned to this device?

This device is registered under product classification code Y061209.

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