Asahi Kasei Medical Co., Ltd.

Certificate HZ 2047383-1

Rev. Rev.3Issued

Valid until: Jun 13, 2027

Certificate HZ 2047383-1 is a valid Quality management system issued to Asahi Kasei Medical Co., Ltd. and registered in EUDAMED. Valid until June 13, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2047383-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2047383-1Rev.3

Validity

Issued: Jan 26, 2024
Valid from: Jan 26, 2024
Valid until: Jun 13, 2027

Manufacturer

Manufacturer: Asahi Kasei Medical Co., Ltd.
Manufacturer SRN: JP-MF-000013951
Manufacturer country: Japan

Notified body

Notified body
Notified body SRN: 0197
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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

F010601 - HAEMODIALYSIS, HAEMOFILTRATION, HAEMODIAFILTRATION FILTERS DIALYSERS - UFC < 18 ml/h/mmHg F010602 - HAEMODIALYSIS, HAEMOFILTRATION, HAEMODIAFILTRATION FILTERS DIALYSERS - UFC = 18 - 35 ml/h/mmHg F010603 - HAEMODIALYSIS, HAEMOFILTRATION, HAEMODIAFILTRATION FILTERS DIALYSERS - UFC > 35 ml/h/mmHg B030201 - APHERESIS THERAPY DEVICES PLASMAPHERESIS DEVICES AND KITS B030203 – APHERESIS THERAPY DEVICES SINGLE PLASMA COMPONENTS REMOVAL DEVICES AND KITS
Class IIb

Documents

LanguagesEN