GUDIDData
eudamed_udi Primary ID: 08800060100014

Unspecified Brand (UDI 08800060100014)

Manufactured by REMEDI Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unspecified Brand - Primary ID 08800060100014

Device Regulatory Overview

The Unspecified Brand (Model/Catalog Number: REM-IFU-T(K)100_Instruction For Use) is a medical device manufactured by REMEDI Inc.. This product is indexed under FDA Product Code / Category Classification Z11039016 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
REM-IFU-T(K)100_Instruction For Use
Product Code / EMDN
Z11039016
Device Name
Portable X-ray equipment
Database Sync Date
2026-08-09 16:48:08

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 Unspecified Brand?

The registered manufacturer of record for Unspecified Brand is REMEDI Inc..

What is the Primary UDI-DI identifier for Unspecified Brand?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08800060100014.

What classification code is assigned to this device?

This device is registered under product classification code Z11039016.

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