EUDAMED update: Jun 2, 2025

SEWONMEDIX Inc.

KR-MF-000016194

Active1,547 devices

Address: Sasang-ro 375beon-gil, #29 46946 Busan
Role: Manufacturer
Date of registration: Nov 8, 2021
Country: South Korea

SEWONMEDIX Inc. is a medical device manufacturer registered in EUDAMED. The company has 1,547 devices on the EU market in South Korea. It holds 1 valid CE certificate. Headquartered in Busan, South Korea. Explore the regulatory profile, devices and certificates on MD Atlas.

About SEWONMEDIX Inc.

: KR-MF-000016194
Role: Manufacturer
Country: South Korea
Organization name: SEWONMEDIX Inc.
EU VAT number: 606-86-42097
Trade register: 606-86-42097
Date of registration: Nov 8, 2021

Contact details for SEWONMEDIX Inc.

Phone: +82513031713
Email: info@sewonmedix.com
Website: www.sewonmedix.com
Address: #29, SASANG-RO 375BEON-GIL SASANG-GU, BUSAN, KOREA 46946 BUSAN SOUTH KOREA

Competent authority

Name: Malta Medicines Authority

Phone: +356 23439000
Email: devices.medicinesauthority@gov.mt

Officers and regulatory representatives of SEWONMEDIX Inc.

KIM JUNYANG
- Conformity of the product device to the Medical Device Regulation and Quality Management System - Conformity of the Technical Documentation and EU Declaration of conformity - Compliance with Post-Market Surveillance (PMS) following Article 10 - Compliance with the Vigilance Reporting obligations (Article 87 to 91) - For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)
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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH6020`	`08800041348923`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCARH4530D`	`08800041358533`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCARH4510D`	`08800041358526`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCAMH4030`	`08800041358458`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCAMN4030`	`08800041358472`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCARH4530`	`08800041358496`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCARH4510`	`08800041358489`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCAMN4010`	`08800041358465`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCAMH4010`	`08800041358441`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCARN4510`	`08800041358502`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCARN4530`	`08800041358519`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMMN4510`	`08800041349128`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH6530`	`08800041348961`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH4530`	`08800041348848`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH4520D`	`08800041348985`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH6020D`	`08800041349074`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH5020D`	`08800041349012`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH5010D`	`08800041349005`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRN4520`	`08800041349166`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH4510`	`08800041348824`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRN5520`	`08800041349227`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH5030`	`08800041348879`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH6520`	`08800041348954`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMMN4520`	`08800041349135`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH6030D`	`08800041349081`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH6020`	`08800041348923`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCARH4530D`	`08800041358533`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCARH4510D`	`08800041358526`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCAMH4030`	`08800041358458`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCAMN4030`	`08800041358472`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCARH4530`	`08800041358496`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCARH4510`	`08800041358489`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCAMN4010`	`08800041358465`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCAMH4010`	`08800041358441`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCARN4510`	`08800041358502`	1	On the market
IH CCM Casting Abutment	IH CCM Casting Abutment	`AIHCCARN4530`	`08800041358519`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMMN4510`	`08800041349128`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH6530`	`08800041348961`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH4530`	`08800041348848`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH4520D`	`08800041348985`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH6020D`	`08800041349074`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH5020D`	`08800041349012`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH5010D`	`08800041349005`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRN4520`	`08800041349166`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH4510`	`08800041348824`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRN5520`	`08800041349227`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH5030`	`08800041348879`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH6520`	`08800041348954`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMMN4520`	`08800041349135`	1	On the market
IH FreeMilling Abutment	IH FreeMilling Abutment	`AIHFMRH6030D`	`08800041349081`	1	On the market

SEWONMEDIX Inc.

About SEWONMEDIX Inc.

Contact details for SEWONMEDIX Inc.

Competent authority

Officers and regulatory representatives of SEWONMEDIX Inc.

Export the 1,547 devices of SEWONMEDIX Inc.

Related searches

About SEWONMEDIX Inc.

Contact details for SEWONMEDIX Inc.

Competent authority

Officers and regulatory representatives of SEWONMEDIX Inc.

Statistics for SEWONMEDIX Inc.

Certificate health for SEWONMEDIX Inc.

Related documents

Devices by risk class

Device catalog for SEWONMEDIX Inc.

Device families (Basic UDI-DI) of SEWONMEDIX Inc.

Market presence of SEWONMEDIX Inc.

Export the 1,547 devices of SEWONMEDIX Inc.

Related searches

Certificate health for SEWONMEDIX Inc.

Statistics for SEWONMEDIX Inc.

Market presence of SEWONMEDIX Inc.

Devices by risk class

Related documents

Device families (Basic UDI-DI) of SEWONMEDIX Inc.

Device catalog for SEWONMEDIX Inc.