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Basic Information
- Number
- HZ 2047383-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- January 26, 2024
- Expiry Date
- June 13, 2027
- Revision
- Rev.3
- Manufacturer
- Asahi Kasei Medical Co., Ltd.
Certificate Lifecycle
Device Characteristics
Scopes
Quality Procedure 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
Basic UDI-DIs
This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.