Samyang Biopharm Corporation

Certificate 2024-MDR/TD-067/B

Rev. 02Amended

Valid until: Dec 12, 2029

Certificate 2024-MDR/TD-067/B is a valid Technical documentation 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/TD-067/B
Certificate type: Technical documentation
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 22652024-MDR/TD-067/B02

Validity

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

Manufacturer

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

History

Status changes

Amended

Supersedes

2024-MDR/TD-067/ATechnical documentationSupplementedNov 11, 2025 → Dec 12, 2029

Scope coverage

Unspecified1

1 scope

Absorbable Knotless Wound Closure Device
880936647KM01MT

Documents

LanguagesEN