Opening a New Path in Distribution
with MDREX CSO Services

A Smart CSO Solution Bridging Regulation and Market

At MDREX, we specialize in CSO (Contract Sales Organization) distribution services designed for a
wide range of medical device categories, including non-active devices, active devices, implantable devices,
active implantable medical devices (AIMD), SaMD/SiMD, in vitro diagnostic (IVD) devices, and Digital Health.

Our One-Stop Solution

From regulatory approval to commercialization — MDREX provides everything you need for a successful launch in Korea.

STEP 01 playlist_add_check

Regulatory &
Reimbursement Consulting

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STEP 02 flag

Market Entry Strategy

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STEP 03 list_alt_check

Regulatory Approval Support

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STEP 04 business_center

Commercialization
(Sales & Distribution)

Service Highlights

Professional Distribution Management

Customized distribution channel design tailored to device characteristics

Data-driven Strategy Development

Market analysis, client-specific reporting, and actionable business insights based on sales performance and distribution data

PRODUCT

Notice

Opening a New Path in Distribution
with MDREX CSO Services

Neurology/Neurointervention

FHC

STarDrive Encoder Motor System

Stereotaxic unit, non-frame

Item Name	Stereotaxic unit, non-frame
Approval Number	수신24-869호
Approval Date	2024-05-16
Class	1
Manufacturer	FHC, Inc.

관리자 2025-11-25 119

Orthopedics

LENTO

PtoleKnee Surgical Guide

Guide for medical use, invasive, single use

Item Name	Guide for medical use, invasive, single use
Approval Number	수인25-4292호
Approval Date	2025-05-20
Class	2
Manufacturer	Lento Medical Innovation, Inc.