Jafron Biomedical Co., Ltd.

Certificate G10 103949 0007

Rev. Rev. 00Issued

Valid until: Aug 21, 2029

Certificate G10 103949 0007 is a valid Quality management system issued to Jafron Biomedical Co., Ltd. and registered in EUDAMED. Valid until August 21, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 103949 0007
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 103949 0007Rev. 00

Validity

Issued: Aug 22, 2024
Valid from: Aug 22, 2024
Valid until: Aug 21, 2029

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
Notified body country: Germany

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

F010702 - HAEMOPERFUSION RESIN FILTERS ; The Cytokine Adsorption Column is a non-pyrogenic, sterile, single use polymer based adsorption system designed for the extracorporeal therapies to remove Inflammatory Mediators represented by Cytokines, P2Y12-Inhibitor represented by Ticagrelor, Factor Xa-Inhibitor represented by Rivaroxaban, Bilirubin and Myoglobin to alleviate the deterioration of the disease.
Class IIb
F010702 - HAEMOPERFUSION RESIN FILTERS ; Disposable Hemoperfusion Cartridge can be used in extracorporeal blood circuits, it is indicated to remove medium-macromolecular toxins represented by β2-MG and protein-bound toxins represented by IS in end stage renal disease, and alleviate the deterioration of the disease caused by the complex pathophysiological changes related to the excessive presence of harmful substances.
Class IIb

Documents

LanguagesEN

Scope coverage

Class IIb2

2 scopes

F010702 - HAEMOPERFUSION RESIN FILTERS ; The Cytokine Adsorption Column is a non-pyrogenic, sterile, single use polymer based adsorption system designed for the extracorporeal therapies to remove Inflammatory Mediators represented by Cytokines, P2Y12-Inhibitor represented by Ticagrelor, Factor Xa-Inhibitor represented by Rivaroxaban, Bilirubin and Myoglobin to alleviate the deterioration of the disease.
Class IIb
F010702 - HAEMOPERFUSION RESIN FILTERS ; Disposable Hemoperfusion Cartridge can be used in extracorporeal blood circuits, it is indicated to remove medium-macromolecular toxins represented by β2-MG and protein-bound toxins represented by IS in end stage renal disease, and alleviate the deterioration of the disease caused by the complex pathophysiological changes related to the excessive presence of harmful substances.
Class IIb

Certificate G10 103949 0007

Overview

Validity

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Certificate G10 103949 0007

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Manufacturer