S.THEPHARM Co., Ltd.

Certificate 2025-AXVI/QS-001/A

Rev. 01Supplemented

Valid until: Nov 14, 2030

Certificate 2025-AXVI/QS-001/A is a valid Quality management system issued to S.THEPHARM Co., Ltd. and registered in EUDAMED. Valid until November 14, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 2025-AXVI/QS-001/A
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 22652025-AXVI/QS-001/A01

Validity

Issued: Jun 26, 2026
Valid from: Jun 26, 2026
Valid until: Nov 14, 2030

Manufacturer

Manufacturer: S.THEPHARM Co., Ltd.
Manufacturer SRN: KR-MF-000020813
Manufacturer country: South Korea

Notified body

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

Covered devices

Cross-linked Hyaluronic Acid injectable gel with Lidocaine / QTFILL PLUSClass III
88000490QTFPRH

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: Yes
SPP applicable

History

Status changes

Supplemented

Supersedes

2025-AXVI/QS-001Quality management systemIssuedNov 14, 2025 → Nov 14, 2030

Scope coverage

Class III2

2 scopes

RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Class III
DEVICE
Class III

Documents

LanguagesEN