Rmedica Co.,Ltd

Certificate 2023-MDR/QS-029

Rev. 00Issued

Valid until: Sep 8, 2028

Certificate 2023-MDR/QS-029 is a valid Quality management system issued to Rmedica Co.,Ltd and registered in EUDAMED. Valid until September 8, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 2023-MDR/QS-029
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652023-MDR/QS-02900

Validity

Issued: Sep 8, 2023
Valid from: Sep 8, 2023
Valid until: Sep 8, 2028

Manufacturer

Manufacturer: Rmedica Co.,Ltd
Manufacturer SRN: KR-MF-000023104
Manufacturer country: South Korea

Notified body

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

Covered devices

Dr.PRPClass IIa
880941020DrPRPMB

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: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

APHERESIS DEVICES - OTHER
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN