Taewoong Medical Co., Ltd.

Certificate KR24/00000045

Rev. 5Supplemented

Valid until: Jun 11, 2029

Certificate KR24/00000045 is a valid Quality management system issued to Taewoong Medical Co., Ltd. and registered in EUDAMED. Valid until June 11, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: KR24/00000045
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 5
Certificate ID: 1639KR24/000000455

Validity

Issued: Nov 14, 2025
Valid from: Nov 14, 2025
Valid until: Jun 11, 2029

Manufacturer

Manufacturer
Manufacturer SRN: KR-MF-000007515
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 1639
Notified body country: Belgium

Covered devices

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented
Supplemented

Supersedes

KR24/00000045Quality management systemSupplementedOct 10, 2025 → Jun 11, 2029

Scope coverage

Class IIb9Class IIa2

11 scopes

MDN1104, MDS1005 EMDN: P0501
Class IIb
MDN1104, MDS1005 EMDN: P0503
Class IIb
MDN1202, MDS1005
Class IIa
DEVICE
Class IIb
DEVICE
Class IIb
Sterile Niti-S Pyloric/Duodenal Uncovered Stent intended for maintaining pyloric/duodenal luminal patency caused by intrinsic and/or extrinsic malignant strictures
Class IIb
Sterile Niti-S Pyloric/Duodenal Covered Stent intended for maintaining pyloric/duodenal luminal patency caused by intrinsic and/or extrinsic malignant or benign strictures
Class IIb
Sterile Niti-S Pyloric/Duodenal Covered Stent intended for maintaining pyloric/duodenal luminal patency caused by intrinsic and/or extrinsic malignant strictures
Class IIb
Sterile Niti-S Enteral Colonic Covered Stent intented for maintaning colon luminal patency
Class IIb
Sterile Niti-S Enteral Colonic Covered Stent intented for maintaning colon luminal patency
Class IIb
Sterile Single-use Guidewire
Class IIa

Documents

LanguagesEN