Star Sports Medicine Co., Ltd.

Certificate M.2024.MDR.1050

Rev. 00Issued

Valid until: Sep 22, 2028

Certificate M.2024.MDR.1050 is a valid Quality management system issued to Star Sports Medicine Co., Ltd. and registered in EUDAMED. Valid until September 22, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: M.2024.MDR.1050
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2696M.2024.MDR.105000

Validity

Issued: Sep 23, 2024
Valid from: Sep 23, 2024
Valid until: Sep 22, 2028

Notified body

Notified body: UDEM Adriatic d.o.o.
Notified body SRN: 2696
Notified body country: Croatia

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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

Sterile Disposable Plasma Surgical Electrodes
Class IIb
Plasma Surgical System Generator
Class IIb

Documents

LanguagesEN