S.THEPHARM Co., Ltd.

Certificate 2025-AXVI/TD-001/A

Rev. 01Supplemented

Valid until: Nov 14, 2030

Certificate 2025-AXVI/TD-001/A is a valid Technical documentation 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/TD-001/A
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 22652025-AXVI/TD-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

Linked SSCPs

SSCP STP-KR-MF-000020813 SSCP-01

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

Supplemented

Supersedes

2025-AXVI/TD-001Technical documentationIssuedNov 14, 2025 → Nov 14, 2030

Scope coverage

Class III1

1 scope

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

Documents

LanguagesEN