GUDIDData
gudid Primary ID: DUMI-350A

DUMI ManipulatOR (UDI DUMI-350A)

Manufactured by THE O R COMPANY PTY LTD

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DUMI ManipulatOR - Primary ID DUMI-350A

Device Regulatory Overview

The DUMI ManipulatOR (Model/Catalog Number: DUMI-350A) is a medical device manufactured by THE O R COMPANY PTY LTD. This product is indexed under FDA Product Code / Category Classification LKF within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
DUMI-350A
Product Code / EMDN
LKF
Device Name
Diagnostic Uterine Manipulator Injector
Database Sync Date
2026-08-09 09:38:27

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 DUMI ManipulatOR?

The registered manufacturer of record for DUMI ManipulatOR is THE O R COMPANY PTY LTD.

What is the Primary UDI-DI identifier for DUMI ManipulatOR?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is DUMI-350A.

What classification code is assigned to this device?

This device is registered under product classification code LKF.

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