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Opening a New Path in Distribution
with MDREX CSO Services

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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.

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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

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Data-driven Strategy Development

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

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PRODUCT

Opening a New Path in Distribution
with MDREX CSO Services

Contact Us
Neurology/Neurointervention
FHC

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 36
Orthopedics
LENTO

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.
관리자 2025-11-25 16
Neurology/Neurointervention
FHC

STarDrive Manual System

  • Item Name : STarDrive Manual System
  • Approval Number : 수신24-868호
  • Approval Date : 2024-05-16
  • Class : 1
  • Manufacturer : FHC, Inc.
관리자 2025-11-25 9
Neurology/Neurointervention
FHC

Nerve locating system, battery-powered

  • Item Name : Nerve locating system, battery-powered
  • Approval Number : 수신25-4085호
  • Approval Date : 2025-02-10
  • Class : 2
  • Manufacturer : FHC, Inc.
관리자 2025-11-25 8
Neurology/Neurointervention
FHC

Electrode, cortical

  • Item Name : Electrode, cortical
  • Approval Number : 수신25-23호
  • Approval Date : 2025-02-18
  • Class : 4
  • Manufacturer : FHC, Inc.
관리자 2025-11-25 11
Orthopedics
LENTO

C2AXXA1

  • Product Code : C2AXXA1
  • Approval Number : D 수인 25-4011호
  • Approval Date : 2025-06-11
  • Class : 2
  • Manufacturer : Lento Medical Innovation, Inc.
관리자 2025-11-25 10