Shin poong Pharm Co.,Ltd.

Certificate 2022-MDR/QS-023/A

Rev. 01Amended

Valid until: Sep 27, 2027

Certificate 2022-MDR/QS-023/A is a valid Quality management system issued to Shin poong Pharm Co.,Ltd. and registered in EUDAMED. Valid until September 27, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 2022-MDR/QS-023/A
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 22652022-MDR/QS-023/A01

Validity

Issued: Oct 6, 2023
Valid from: Oct 6, 2023
Valid until: Sep 27, 2027

Notified body

Notified body: 3EC International a.s.
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

No specific devices are listed for this certificate.

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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Status changes

Amended

Supersedes

2022-MDR/QS-023Quality management systemIssuedSep 27, 2022 → Sep 27, 2027

Scope coverage

Class III4

4 scopes

MEDICURTAIN®(Antijoin) Anti-Adhesion Barrier HA Gel 1.2mL
Class III
MEDICURTAIN®(Antijoin) Anti-Adhesion Barrier HA Gel 2mL
Class III
MEDICURTAIN®(Antijoin) Anti-Adhesion Barrier HA Gel 5mL
Class III
Anti-Adhesion Barrier HA Gel
Class III

Documents

LanguagesEN