Samyang Biopharm Corporation

Certificate 2024-MDR/QS-067/B

Rev. 02Amended

Valid until: Dec 12, 2029

Certificate 2024-MDR/QS-067/B is a valid Quality management system issued to Samyang Biopharm Corporation and registered in EUDAMED. Valid until December 12, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 2024-MDR/QS-067/B
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 22652024-MDR/QS-067/B02

Validity

Issued: Jan 5, 2026
Valid from: Jan 5, 2026
Valid until: Dec 12, 2029

Manufacturer

Manufacturer
Manufacturer SRN: KR-MF-000037085
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

Absorbable Knotless Wound Closure DeviceClass III
880936647KM01MT

Characteristics

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

History

Status changes

Amended

Supersedes

2024-MDR/QS-067/AQuality management systemSupplementedNov 11, 2025 → Dec 12, 2029

Scope coverage

Class III2

2 scopes

Mounted polydioxanone monofilament with needle for tissue traction (‘barbed’) Absorbable Knotless Wound Closure Device
Class III
DEVICE
Class III

Documents

LanguagesEN