IVDR IVDR QMS Issued

HX 1108389-1

Basic UDI-DIs
0
Scopes
1
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
Rev.0

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1059
Valid for 1059 days
Expiry: June 20, 2029

Basic Information

Number
HX 1108389-1
Type
IVDR QMS
Legislation
IVDR
Issue Date
June 21, 2024
Expiry Date
June 20, 2029
Revision
Rev.0

Certificate Lifecycle

June 21, 2024 June 20, 2029

Scopes

Quality Procedure Scope

Device Group Class C

HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01030709 - PRIMARY ANTISERA FOR IMMUNOHISTOLOGY

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.