IVDR IVDR QMS Issued

HX 1743284-1

Manufacturer: Sysmex Partec GmbH
Basic UDI-DIs
0
Scopes
1
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
Rev.0

Check certificate HX 1743284-1 in seconds

The Research Assistant checks certificate status, issuer and covered devices — and cites every record.

Free to try · every answer cites its records

722
Valid for 722 days
Expiry: July 18, 2028

Basic Information

Number
HX 1743284-1
Type
IVDR QMS
Legislation
IVDR
Issue Date
July 19, 2023
Expiry Date
July 18, 2028
Revision
Rev.0
Manufacturer
Sysmex Partec GmbH

Certificate Lifecycle

July 19, 2023 July 18, 2028

Scopes

Quality Procedure Scope

Device Group Class C

HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 506: Other devices intended to be used to determine markers of infections/immune status W01030801 - MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS

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.